BALTIMORE--Despite efforts by HME industry groups, lawmakers and even a lawsuit to delay its implementation, CMS' new interim final rule for power mobility devices went into effect on Tuesday. But things could change with a last-minute amendment to the Senate's HHS spending bill, introduced Wednesday by Sen. Arlen Specter (R-Pa.).

In late September, Specter, along with Sen. Rick Santorum (R-Pa.), wrote CMS Administrator Mark McClellan asking for a delay to make transition to the new rule easier. "The absence of a reasonable period for advance preparation to the change in rules may overwhelm PMD providers and manufacturers striving to comply and remain commercially viable," the senators wrote. (See HomeCare Monday, Oct. 3.)

In a separate letter Sept. 29, Senate Finance Committee Chairman Charles Grassley (R-Iowa) also urged McClellan to delay the rule. On Oct. 6, more than 50 mobility advocates from 20 states converged on Capitol Hill seeking a delay. And on Oct. 13, the D.C.-based Power Mobility Coalition filed a federal court motion to stop the rule.

But CMS--which has decided to delay new power wheelchair coding--stuck with its Oct. 25 implementation date for the IFR, though comments on the rule are not due until Nov. 25.

Released on Aug. 26, the IFR created an uproar among mobility stakeholders. The rule eliminates the certificate of medical necessity for PMDs, instead requiring providers to submit only a physician's prescription for reimbursement of Medicare claims--but holding them responsible for producing patient records supplied by physicians that document medical necessity for the equipment.

Many in the industry maintain that CMS did not allow sufficient time to educate all parties about the changes--particularly physicians, whose role has been expanded--and to implement processes to incorporate the new regulations, leading to confusion surrounding claims and making it more difficult for beneficiaries to obtain power wheelchairs and scooters.

In its motion, the PMC charged that, in addition to restricting beneficiary access to PMDs, the IFR would put many of its supplier members out of business. But on the same day the IFR went into effect, a federal district court declined to rule immediately on the organization's request for a preliminary injunction against the rule, apparently because of concerns over jurisdictional issues, according to the PMC.

"The rule creates a new level of uncertainty in the claims approval process that will drive local suppliers out of the program and curtail access to needy beneficiaries," PMC Counsel Steve Azia said in a statement released after the court's deferral. The group said it does expect a ruling on the matter in the near future.

But Specter's amendment may turn out to be a legislative remedy for the IFR's delay. Attached to the Senate's 2006 appropriations bill, which includes spending plans for HHS, Labor and Education (H.R. 3010), the amendment would restrict use of funds to implement or enforce the rule.

Instead, it requires CMS to withdraw the IFR and reissue a proposed rule by Jan. 1, 2006. After a 45-day comment period, a final rule would then be issued by Feb. 14 to take effect April 1, 2006.

The Senate passed the amendment by voice vote, but now the bill must be approved by the House of Representatives--and then it requires the president's signature. According to industry insiders, both are expected before Thanksgiving with Specter's amendment intact.

But until the president signs the bill, the IFR will remain in effect, pointed out Seth Johnson, director of government relations at Pride Mobility and chair of the American Association for Homecare's Rehab and Assistive Technology Council. "When the bill is approved by Congress, we hope that CMS will not wait for the president to sign it before putting this delay into effect," Johnson said in a notice from AAHomecare.

To view the interim final rule, click here.