Associations representing medical technology interests praised the Healthcare Financing Administration (HCFA; Baltimore, Maryland) reorganization initiatives unveiled last month by Heath and Human Services Secretary Tommy Thompson, but they emphasized that they expect follow-up announcements to be even more critical to the reform effort of the Bush administration.

Stephen Northrup, executive director of the Medical Device Manufacturers Association (MDMA; Washington), called Thompson's announcement "the first formal step" by the Bush Administration to put its stamp on Medicare and Medicaid. But these efforts, he told BBI, should be considered "the beginning, not the end of reform."

In a similar tone, the Advanced Medical Technology Association (AdvaMed; Washington) said that the group welcomed the chance "to achieve this goal" of improving the responsiveness of the agency. "Creation of a more responsive structure and culture at the agency will help ensure that America's seniors and people with disabilities gain access to the high-quality, cutting-edge treatments they need," said Carol Kelly, executive vice president, health care systems and federal legislative policy, in a statement from the association.

The changes announced by Thompson can be put into three categories: changing the name of the agency from Health Care Financing Administration to the Centers for Medicare & Medicaid Services (CMS); improving communication, which Thompson called part of a process for instilling "a new culture of responsiveness," and making specific structural changes in the department. A fourth step will be making changes intended to improve contractor processing, including promoting competition among contractors, improving communication between CMS and contractors and offering greater incentives for improved contractor performance.

Under the category of better communication, the Centers for Medicare & Medicaid Services, according to the Thompson announcement, will launch a $35 million media campaign to better inform Medicare clients concerning their health care options. As part of this effort, the agency will "enhance" its current 800 phone service, expanding it from a business-hours-only service to a 24/7 operation and also providing "far more detailed information to help beneficiaries to make Medicare decisions."

And Internet services will include a program to help public libraries in assisting Medicare beneficiaries via the agency web site, www.medicare.gov.

"Quality service," according to HHS's announcement of these efforts, will be "the No. 1 priority in this agency."

The restructuring will include the creation of three "centers" reflecting the agency's primary offerings: the Center for Medicare Management, emphasizing traditional fee-for-service Medicare: the Center for Beneficiary Choices, focusing on Medicare, Medicare Select, Medicare+Choice and Medigap options; and the Center for Medicaid and State Operations, emphasizing various programs administered by states.

Overall, the various initiatives appear to respond to the medical device industry's increasing pleas over the past two to three years for faster decision-making by the agency and Medicare, and the Thompson announcement said that the general purpose will be to create "a culture of responsiveness." The outline of proposals for changing and improving contractor activities emphasizes initiatives that will improve efficiency and flexibility.

Northrup called Thompson's emphasis on responsiveness "a move in the right direction," and he granted that, overall, the agency has been "increasingly responsive to our concerns and increasingly willing to listen to our concerns as time has gone on." He added that, compared to two and one-half to three years ago, the "relationship has certainly been better." Looking to the future, he said that MDMA is "going to take advantage of the administration's interest in doing things to improve the administration of the program that don't necessarily require the passage of laws." At the same time, he said new laws will be necessary, an effort that may be hampered by the recent shift in congressional power. Thus, he estimated the chances for Medicare reform as "a lot slimmer now that the Democrats have taken the Senate."

Peter Ashikanez, spokesman for HHS, said that the department would be offering administrative changes and proposing a variety of legislative proposals to congress "throughout the summer." The intent of both, he told BBI, will be to develop processes "to make it easier and better for the people we work with – all of our customers and stakeholders."

Among others praising the new HCFA initiatives was the American Association of Health Plans, a trade group representing more than 1,000 health maintenance organizations. AAHP President Karen Ignagni said that "Millions of beneficiaries will benefit from increased information on Medicare choices, public education efforts and HCFA's new culture of responsiveness."

No rush to meet reprocessor deadline

U.S. hospitals have only a few more weeks to meet the deadline for doing their own reprocessing of Class II single-use medical devices. But FDA officials say they do not see a lot of hospitals busily ramping up to meet that Aug. 14 deadline.

FDA staffers involved in the process of helping hospitals stay current with the updated guidance on reprocessing, issued by the agency last year, are saying that the requirements may have taken away the economic reason for sterilizing and reusing single use devices (SUDs). Those requirements call for all reprocessors, including hospitals, to submit data equivalent to support of a 510(k) or PMA application for all Class II single-use devices that they clean and reuse.

Lily Ng, of the Office of Surveillance and Biometrics in the Center for Devices and Radiologic Health, is in charge of coordinating efforts to disseminate information concerning reprocessing guidelines, and she said that if hospitals decide to be reprocessors, they will have to look "like a manufacturing site." They will have to have facilities such as receiving areas and decontamination areas and do "what's required to minimally meet the good manufacturing practice requirements," she told BBI.

By reprocessing SUDs, a hospital "automatically becomes a device manufacturer. They have to do MedWatch reporting," are "required to be tracked" and are subject to inspection, the same as manufacturers. Ng said that these efforts will require a hospital to make what she termed "an institutional decision."

She reviewed a variety of attempts by her office and other FDA offices to inform hospitals about the guidelines issued last year, and said, "I hope they are not oblivious, but there's always that problem of some being lost between the cracks."

Besides a variety of mailings to hospitals, the agency has offered several briefing opportunities such as seminars for third-party reprocessors and hospitals. Ng and other staffers reported relatively light turnouts at two May workshops and participation from only a handful of hospitals. Based on that participation, she was reluctant to predict the number of hospitals that would decide to reprocess SUDs. "We have nothing firm," Ng said. "I can tell you that no hospital reprocessor submitted a premarket application back in February, the first deadline for reprocessing medical devices in the Class III category."

Joseph Pulio, chief of the technical assistance branch of the FDA's Division of Small Manufacturers Assistance, was equally reluctant to make a specific prediction, but said that of the approximately 6,000 hospitals around the country, he estimated that fewer than 20% of them would choose to clean and reuse SUDs.

No Comments