CMS' proposal to require manufacturers applying for a new technology APC to request a CPT code could make it more difficult for devices to reach the market, according to device stakeholders.

In the 2006 hospital outpatient prospective payment system proposed rule, the agency proposes that manufacturers include a copy of their CPT application and CPT's letter of acknowledgement or approval in their new technology APC application.

"This requirement will encourage timely review by the wider medical community as CMS is reviewing the service for possible new coding and assignment to a new technology APC under OPPS," states the ^FDL-1 rule, slated for publication in the July 25 Federal Register.

"We believe that consideration by the CPT Editorial Panel may facilitate appropriate dissemination of the new technology services across delivery settings and may bring to light other needed coding changes."

Device stakeholders contend the proposal will have the opposite effect, however. During a July 19 CMS Open Door Forum, Almyra, Inc. VP-Consulting Jo Ellen Slurzberg said that manufacturers often work with specialty societies on CPT coding applications, but the societies submit them.

"You're making a requirement to the manufacturer that the manufacturer really doesn't have control over," she said. "This seems to be a situation where there could actually be a delay in gaining both coverage and payment under the new technology [APC] for some new devices when they hit the market."

Furthermore, Slurzberg said that many manufacturers wait until they have enough evidence to qualify for a Category I CPT code, since Medicare contractors often reject Category III codes denoting emerging technology. CMS' proposal could force firms to file applications prematurely, which could result in non-coverage.

AdvaMed and MDMA agree. MDMA says that with only three CPT deadlines per year that do not coordinate with new tech APC application deadlines, delays would be inevitable.

New tech APCs offer special payments for products ineligible for pass-through payment for two to three years until enough data are available to assign the product to a clinical APC.

New Tech APC Applicants Would Need To File For CPT Code Under OPPS Rule

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