After months of industry advocacy efforts with legislators raising awareness of the need for modifications to the Interim Final Rule, Congress passed language in the Labor, Health and Human Services and Education appropriations bill that “prevents CMS from using any resources to implement or enforce the IFR until April 1, 2006.”
The language instructs CMS to publish a proposed rule with comment period, and a final rule with a 45-day transition period, to be implemented no earlier than April 1, 2006. Since approval of the bill took more time than anticipated, CMS may not meet this timeframe; however, the agency is prevented from implementing or enforcing the IFR until at least that date.
The retraction of the IFR is positive in that it provides additional time for physician education and the development of documentation clarity, which will afford physicians and providers the understanding and acknowledgement of the level of documentation needed to substantiate medical necessity for power mobility devices.
While at this writing no official interim guidance has been issued by CMS, the retraction could also extend the 30-day timeframe between the face-to-face examination requirement and the provider's receiving the prescription and support documentation from the ordering physician.
We do not anticipate major changes with the retraction of the IFR since the National Coverage Determination and Local Coverage Determination remain in effect. The LCD outlines a nine-step examination, to be performed by the treating practitioner, which needs to be accompanied by supportive documentation. The LCD also outlines a seven-element prescription.
The industry now has a real opportunity to work with CMS on improving upon the status quo.
Although there is much in the IFR and LCD that is manageable for providers, physicians and the DMERCs, in order for this new rule to yield reasonable outcomes for the long term, the following is necessary.
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The DMERCs need to issue an official bulletin clarifying the documentation expectations. This would provide physicians with specific guidance as to their responsibilities regarding what constitutes a complete examination and documentation fulfillment that establishes medical necessity.
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Such official guidance should also clarify that medical reviewers need to base medical necessity determinations on the exam questions and existing support documentation, rather than denying a claim for weak or absent historical medical records on a discretionary basis. A historical record cannot materialize if it simply wasn't recorded over the course of a patient's medical treatment history.
Without this reasonable understanding, providers are forced to operate with unfair risk. Such an issuance will help ensure a consistent level of documentation on each claim as well as give providers some reasonable predictability.
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Additionally, relaxing the 30-day timeframe for the face-to-face examination to 60 days also makes for a more reasonable process.
While there are a laundry list of challenges ahead, opportunities also exist. We must recognize, for instance, the increased importance of the provider-physician relationship in this evolved marketplace.
It is now far more essential than ever before to develop professional relationships with physicians and physicians' staffs and create an educational, “information exchange” environment. Relationships need to be created that do, in fact, include providers and physicians as part of the same clinical team.
How do you do that? There is help out there. Pride, for instance, has worked with providers to develop guides on physician resources, choosing the right mobility solution, home assessment and other examination and documentation reference materials in print and Web-based formats.
These materials simplify and clearly outline the examination, documentation and PMD ordering process and policies, and they help clarify the responsibilities and procedures each member of the clinical team needs to follow.
Additionally, we are joining providers in presenting seminars and forums (that offer continuing education units) for physicians and physicians' staffs, as well as therapists.
These things are being done to embrace the need for strong business alliances and to clarify the responsibilities of each member of the clinical team. This will permit physicians to knowingly, simply and efficiently manage their responsibilities, which largely include the examination and the compiling of complete patient information documents.
Some providers are also adding medical staffers to their compliance departments. Medical professionals with backgrounds in such areas as nursing or as physician assistants are joining providers' staffs to enhance the provider-to-physician clinical and business processes.
This clinical model may increase provider costs and could be more difficult to manage on the front end of the ordering and documentation process for PMDs. However, these requirements, which include physician examination and algorithmic documentation requirements followed by a seven-element prescription, should protect providers on the back end (e.g., in claims review and/or hearings) by yielding more complete documentation.
Such an outcome certainly suggests these front-end requirements could be more costly, but worth it to mobility providers in the end.
This outlook also suggests that the physician examination will produce a “global clinical assessment,” and that providers will receive documentation offering a broader medical view of the patient. Such a global clinical view will substantiate a PMD claim and defeat the notion that a claim may be denied because of one missing piece, such as a particular historical record.
The responsibility has been placed on the physician to compile the documentation (via a face-to-face examination), and then — and only then — write and submit a prescription for the product.
This present-day scenario certainly is positive, and the message to providers is to enhance the relationship with physicians via education and up-front and personal communication.
As president of Pride USA, Exeter, Pa., and a member of the Restore Access to Mobility Partnership, Dan Meuser was a strong proponent for delay of the Interim Final Rule on power mobility, which took effect Oct. 25, 2005, but has now been put on hold until at least April 1, 2006. While Meuser pointed out that the industry and CMS worked together for more than a year to come up with a new mobility coverage policy, he cautioned last fall that all the hard work could be jeopardized if the policy were not accompanied by a “clear and concise” set of regulations governing how power wheelchairs and scooters get to the Medicare beneficiaries who need them. Citing a widespread lack of education in the medical community about physicians' new role in the process, in a RAMP statement issued in September Meuser called on CMS to review implications of the IFR and to give providers more time to adjust to its changes. Otherwise, he said, “We are heading towards a train wreck.” What follows are Meuser's reflections on the IFR, its delay — and what lies ahead for the power mobility sector of the home medical equipment industry.