Regulatory:

CMS Publishes Contractor Standards: The Baltimore-based Centers for Medicare and Medicaid Services Feb. 25 published an announcement in the Federal Register, describing the criteria whereby Medicare will evaluate its durable medical equipment regional carriers during 2003. “The results of [these] evaluations are considered whenever we enter into, renew or terminate a … DMEPOS regional carrier contract or take other contract actions,” the Centers for Medicare and Medicaid Services wrote.

Although the proposed standards — which include criteria for claims processing, customer service and fiscal responsibility — took effect March 3, CMS will accept comments on the standards until March 31. More information about these standards is available at www.access.gpo.gov/su_docs/fedreg/a030228c.html, under the CMS heading.

FDA Publishes Device User-Fee Rates: The Feb. 28 Federal Register included payment procedures for the U.S. Food and Drug Administration's new medical-device user fees. Designed to expedite the FDA's approval of new medical devices, the fees first appeared in the Nov. 21, 2002 Federal Register. However, because Congress did not appropriate the necessary funds until Feb. 20, 2003, the FDA was not able to collect the fees until now.

“Accordingly, the FDA will issue invoices for all fees payable for applications submitted between October 1, 2002 and March 31, 2003,” the publication said. “Those invoices will be due and payable within 30 days of issuance.”

Beginning April 1, 2003, applicants must pay for all device reviews at the time of submission, the publication continued. Answers to “frequently asked questions” about medical-device user fees are available at www.access.gpo.gov/su_docs/fedreg/a030225c.html, under the FDA heading.

CMS Issues New KB Modifier: The Baltimore-based Centers for Medicare and Medicaid Services has issued a new modifier — KB — for use when a claim line needs more than four modifiers to support Advanced Beneficiary Notice claims. The KB modifier will alert claims processing staff at the durable medical equipment regional carriers to invoke ABN logic.

People & Places

Graham to Run for President: Sen. Bob Graham, D-Fla., Feb. 27 announced he will run for President of the United States in 2004. Graham has, for more than a decade, been an outspoken proponent of competitive bidding for durable medical equipment, although he has backed away from the issue in recent months.

OIG Secretary Resigns: Amid allegations of mismanagement and high turnover among personnel — which culminated in a request from Sen. Chuck Grassley, R-Iowa, for a General Accounting Office investigation — Janet Rehnquist, secretary of the U.S. Office of Inspector General, will resign effective June 1. Kevin McAnaney, chief of the OIG's industry guidance branch, also will resign effective May 2.

HHS Names AHRQ Director: The U.S. Health and Human Services Department has appointed Carolyn Clancy director of its Agency for Healthcare Research and Quality. Clancy previously was director of AHRQ's Center for Outcomes and Effectiveness Research.

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