News & Events

Jack Galiardo cites changes at FDA and in Medicare and global market as priorities

JOHN W. (JACK) GALIARDO, HIMA's new chairman for 1998 and vice chairman of the board and general counsel, Becton Dickinson and Company, outlined new challenges for Association members in the wake of last year's successful effort to enact FDA reform legislation, saying, "The world is moving on."

In his inaugural address to members at HIMA's Annual Meeting, Galiardo praised last year's record of accomplishments, which included the FDA Modernization Act, initialing of a mutual recognition agreement between the EU and the U.S., drastic reductions in proposed cutbacks in reimbursement rates for medical technology in Japan, and repeal of the cooperative purchasing program of the Federal Acquisition Streamlining Act.

"This past year, we've seen HIMA at its best. And in the coming year, our best is called for yet again," Galiardo said. "We are faced with a number of challenges and opportunities that we as an industry would be foolish to neglect," he continued.

He cited "refreshing changes" at the FDA that provide an opportunity for HIMA to work with the Agency in ongoing reengineering efforts at CDRH, implementation of the Modernization Act, and working collaboratively with the Agency in finding ways to speed up the product cycle time for medical technology—the time from design and development of a product through its review and approval.

"Safeguarding the industry's future means protecting the process of innovation, and that often translates into looking out for the special needs of creative small companies," Galiardo said. "In working with the FDA in these important matters, I see a special, continuing role for HIMA's Small Company Council and a further strengthening of the working relationships that we have established with regional industry groups."

Moving on, Galiardo said a reorganization underway at the Health Care Financing Administration (HCFA) and recent Medicare reform legislation that HCFA must implement present important challenges to HIMA. "If Medicare will not readily pay for new technologies, then we have a potential impediment to innovation," Galiardo declared. "We want a decision-making process for Medicare coverage that is timely, fair, rational and accountable to both patients and technology developers. We also want to ensure that the process of technological innovation is valued by HCFA and is reflected in its coverage and payment policies and procedures."

HIMA's priorities for the coming year also must include working for passage of legislation to provide legal protections to biomaterials suppliers and heightened concern about medical technology regulatory and reimbursement issues in nations around the globe.

"In the past decade, we have come to understand that each international market poses its own unique and complex challenge," he said. " FDA reform in the United States and ongoing reforms in Japan are just a warm-up for the larger tasks of demolishing regulatory barriers and harmonizing standards in the vast global marketplace. And it is the global marketplace where manufacturers—no matter where they are located—are going to find their future."

Galiardo concluded by asking HIMA members to stay involved in the Association's list of public policy issues. "The tasks ahead of us will require your continued participation and your dedication. The future requires that all of us at HIMA work together. Let us finish what we have started," he declared.

The incoming chairman's remarks preceded a members-only HIMA Town Hall discussion, moderated by HIMA President Alan H. Magazine, in which Board Committee chairs briefed the membership on the status of current issues and heard comments from the floor. The topics covered included global technology market issues, implementation of the FDA Modernization Act, proposed biomaterials legislation, Medicare reform and the HCFA re-organization.