Seldom has an industry faced as much scrutiny as HME suppliers during the past 18 months. Last year saw the initial enforcement of Operation Wheeler Dealer as well as enactment of the MMA. In the wake of these tumultuous events, increased scrutiny has been placed not only on the HME industry generally, but especially on power mobility suppliers.

Although Operation Wheeler Dealer had many provisions that impacted all HME suppliers, the brunt of enforcement fell primarily on HME suppliers providing power mobility products. As a result, 2004 has been a particularly bleak year for power mobility suppliers and the outlook for the immediate future is not particularly bright.

The MMA contained provisions that could have been viewed as good news for power mobility suppliers, since reimbursement for power mobility products was cut less than some other items. However, in the wake of the MMA, newly proposed regulations promise to place additional burdens on power mobility suppliers in areas such as obtaining physician documentation to support medical necessity. As a result of these and other developments, suppliers must keep up with current trends in legal and regulatory enforcement to ensure they are aware of the guidelines.

The Face-to-face regulation
When it was enacted in 2003, the MMA included a provision that indicated that Medicare would cover a power wheelchair only if a physician, physician assistant, nurse practitioner, or clinical nurse specialist ordered the chair after a face-to-face examination of the patient. On August 5, 2004, CMS published in the Federal Register regulations to accomplish the goals of this provision. To the surprise of many HME suppliers, these face-to-face regulations imposed requirements not only on power mobility suppliers but on suppliers providing the entire range of HME. Under the proposed regulations, Medicare will only pay for HME that is ordered by a physician, physician assistant, nurse practitioner, or clinical nurse specialist under the following circumstances:

• The physician or prescribing practitioner must conduct a face-to-face examination of the patient to determine medical necessity. This examination must be conducted prior to the initial order and prior to renewal of items requiring prescription renewals such as infusion pumps or hospital beds. In addition, the physician or practitioner performing the examination must not be employed by or contracted to the HME supplier.

• A written order must be completed and signed before delivery of any HME to the beneficiary.

• The physician or prescribing practitioner’s order must be dated and signed within 30 days after the face-to-face examination, and this face-to-face examination must be reflected in the beneficiary’s medical record.

• The physician’s medical record must document the need for HME.

• Medicare will not pay for any face-to-face examination that is conducted for the sole purpose of obtaining the physician’s or prescribing practitioner’s order for HME.

If these rules are adopted as proposed, then many HME suppliers will be forced to drastically change their policies and procedures for obtaining physician orders. Many suppliers still use verbal dispensing orders for power chairs and other products. However, this verbal dispensing order will no longer be valid and the supplier will need to obtain the written order prior to delivery for all products and services. In addition to forcing policy changes concerning verbal orders, the proposed regulations may also change some companies’ policies regarding patient referrals to physicians for the purpose of qualifying the patient for HME.

In its commentary on the proposed rules, CMS states, “We expect the prescribing physician or practitioner to conduct a sufficient examination of the patient’s medical condition to ascertain the appropriate overall treatment plan and to order the DMEPOS as only one aspect of that treatment plan.” Since the regulations are currently proposed regulations only, suppliers had until September 24, 2004, to provide comment to CMS concerning these regulations.

Maximum Comfort
Power mobility suppliers should be aware of developments such as the Maximum Comfort case, proposed regulations for HME suppliers under the MMA, and payment review and audit activities of the Durable Medical Equipment Regional Carriers (DMERCs). In Maximum Comfort Inc v Tommy G. Thompson et al, the US District Court for the Eastern District of California ruled that Region D cannot require proof of medical necessity other than the Certificate of Medical Necessity (CMN).

In the decision handed down on June 28, 2004, the court stated that Congress addressed the issue of medical necessity documentation in 42 USC § 1395m(j). That section provides that a “CMN means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”—42 USC § 1395m(j)(2)(B).

The Health and Human Services (HHS) Secretary’s contention that Congress provided him with the authority to decide what documentation may be required to determine medical necessity conflicts with the plain meaning of § 1395m(j)(2)(B). That section plainly specifies that Congress intended that whatever information may be required by carriers from suppliers to show the medical necessity and reasonableness of HME must be contained in a CMN—the CMN thus complies with Congress’ mandate.

Given the above, no room is left for requiring further documentation because the court concluded that the plain language of §1395m(j)(2)(A)(i) supported the plaintiff’s position that it may use a CMN only to provide the necessary information for the determination of medical necessity and reasonableness. Although the direct impact of Maximum Comfort is limited to the Eastern District of California, suppliers in other parts of the country can use Maximum Comfort as guidance for cases brought in their own districts or cases brought before carrier hearings or Administrative Law Judge (ALJ) hearings. Despite the fact that the Maximum Comfort case is not binding outside the Eastern District of California, its reasoning could be persuasive in cases throughout the country. It is also important to monitor the procedural progress that Maximum Comfort makes through the Ninth Circuit Court of Appeals. If the government chooses to appeal the case, then any decision reached by the Ninth Circuit would be binding in all of those states that comprise the Ninth Circuit.

If the Ninth Circuit upheld the decision made by the District Court in the Eastern District of California, this would add to the persuasive authority of the Maximum Comfort case to courts in other circuits and districts throughout the country. Ultimately, if the Maximum Comfort case is appealed to the US Supreme Court, the Supreme Court’s decision would be binding on courts throughout the country. This would be excellent news for HME suppliers if the Supreme Court upheld the District Court’s decision. However, a Supreme Court determination is several steps down the road and is not likely to clarify this issue for suppliers in the foreseeable future.

For the time being, suppliers outside the Eastern District of California should use the Maximum Comfort decision as a basis for support of their medical documentation and power mobility medical review procedures. It is unlikely that Carrier Fair Hearing officers will be persuaded by the Maximum Comfort decision. However, ALJs may be persuaded and suppliers lose nothing by presenting the argument at both the Carrier Fair Hearing level and at the ALJ level.

However, suppliers should not rely entirely on Maximum Comfort in supporting the quality of their medical review documentation and should continue to send and collect additional physician documentation showing the patient’s need for power mobility products. Until such time as the Maximum Comfort case is made applicable to a broader range of parties, suppliers should anticipate that DMERCs will continue to insist on physician documentation in the form of physician notes that support the medical necessity for HME .

DMERC Payment Audits
DMERCs are increasing the frequency of their documentation audits on power mobility suppliers. Suppliers with a particularly high volume of power mobility products or suppliers who are newly enrolled in the Medicare program can expect to have a significant portion, if not all, of their power mobility claims reviewed by the DMERC’s medical review department. There has been discussion between CMS and the industry concerning exactly what documentation is required to be a part of the physician’s medical record.

CMS and the DMERCs continue to be somewhat vague concerning what constitutes adequate documentation, and it is apparent from reviewing the results of the DMERC’s payment review audits that the DMERCs are increasingly critical of suppliers’ documentation. In conducting self-audits or collecting documentation for prepayment or postpayment review, keep in mind the following key elements to any power mobility chart: 1) charts must contain physician notes (or notes from an independent source such as a home health agency or physical therapist) that document the reason for the patient’s inability to ambulate without the assistance of a wheelchair; 2) these notes must contain information indicating why the patient lacks the upper body strength to operate a manual wheelchair; and 3) suppliers should scrutinize their charts to verify that there is no reason to believe that the patient cannot safely operate the wheelchair that was prescribed. For instance, if the patient’s medical record contains a diagnosis of Parkinson’s disease and the doctor has noted severe tremors, then the HME supplier should have additional documentation indicating that it has verified that the patient can operate the power chair safely.

Prepare to provide documentation supporting each of these areas to the DMERC medical review department. Power mobility suppliers continue to face a dim prospect of relief from DMERC and NSC scrutiny in the short term. However, by taking appropriate steps to prepare for payment audits, regulations, and challenges under provider enrollment, power mobility suppliers can be prepared for the long haul.

Clay Stribling, JD, is an attorney with the Health Care Group of Brown & Fortunato PC, an Amarillo, Tex-based law firm. Stribling represents HME companies, pharmacies, and other health care providers throughout the United States and Puerto Rico. He can be reached at (806) 345-6346 or via email: cstribling@bf-law.com.