AdvaMed is hoping that the final draft of Medicare regulatory relief legislation will include a provision authorizing the council for technology and innovation within the Centers for Medicare & Medicaid Services to be led by a political appointee.

Sec. 502 of the "Medicare, Regulatory and Contracting Reform Act of 2001" (HR 3391), passed by the House Dec. 4, says that an "executive coordinator" should chair the council. Designated by the HHS secretary, the individual would be a non-career appointee reporting to the CMS administrator, who would act as a single point of contact between CMS and stakeholders regarding the coverage and coding of payment processes for new technologies, the bill states.

The House bill was a hybrid of two separate measures that were introduced in the House Ways & Means and Energy & Commerce Committees this fall.

The Ways & Means version incorporated elements of the "Medicare Innovation Responsiveness Act" (HR 2973), introduced by Reps. Jim Ramstad (R-Minn.) and Karen Thurman (D-Fla.). While the legislation provided for the creation of an "office" of technology and innovation within CMS, the name was later changed to a "council" as a compromise to Democrats and CMS staffers, who opposed the idea of establishing an entirely new office (¹ [A#01270410010], p. 13). Provisions of the Ramstad/Thurman measure left out of the consensus bill likely will be brought up again next year, staffers say.

The Senate version of the measure, introduced by the Finance Committee Nov. 28, does not currently contain language establishing a council. The provision is expected to be included in a merged version of the two bills; however, the Senate is not expected to take up the measure until January.

AdvaMed will use the extra time to try to convince the Senate of the need for a political appointee to lead the technology council. The association says it would support an individual from outside of the CMS who was familiar with the current system but also eager to make reforms.

An example of a candidate who would meet the criteria might be Medtronic Chairman William George, who left his CEO post May 1 after 11 years at the Minnesota firm (² [A#01260350005], p. 9). George is set to relinquish his chairmanship to current CEO Arthur Collins next May.

Another person that might be viewed as qualified for the position is C.R. Bard Chairman/CEO and current AdvaMed chairman William Longfield, who also leads the association's Medical Technology Preparedness Council. After his one-year term ends at AdvaMed in March, Longfield, whose firm is located in Murray Hill, New Jersey, may be eager to continue his work in the Washingon, D.C. area representing industry on the policy side. Guidant's President and CEO Ron Dollens also would probably have AdvaMed's support if he were named to the post.

While the association has not formally endorsed a specific candidate, it has expressed a desire to be involved in the selection process.

In general, AdvaMed supports the House-passed version of Medicare regulatory relief legislation, which establishes a more transparent, predictable process for establishing Medicare reimbursement rates for new diagnostic tests. "The House took major strides today to...ensure that Medicare can keep pace with rapid advances in diagnostic testing and other medical technologies," AdvaMed President Pam Bailey remarked Dec. 5. "We urge the Senate to quickly pass similar legislation and make these benefits a reality for America's seniors."

The measure was considered late the evening of Dec. 4 under a suspension of the rules and passed 408-0. It sets specific timeframes for the release of new rules, allows greater flexibility in selecting Medicare contractors, and provides for education and technical assistance to providers.

"This bill will place additional administrative burdens on CMS," Ways & Means/Health Subcommittee Ranking Member. Pete Stark (D-Calif.) noted during floor debate earlier in the day. "We will continue to see that Labor/HHS appropriation bills provide modest increases in administrative resources for CMS to complete this work," he pledged. The House and Senate could begin work on a Labor/HHS conference report as early as the week of Dec. 10.

However, despite placing additional burden on CMS, the measure will "assist the medical device manufacturing community, enhancing the communications and cooperation between the FDA and CMS," Rep. Steve Buyer (R-Ind.) noted. "This is an excellent bill."

House Approves Medicare Regulatory Relief, Senate Will Address Bill In 2002

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