Lawmakers, physicians and patients came together late last month on Capitol Hill to highlight the problem of reducing the amount of time it takes to get new technologies covered by the Medicare program. Reps. Ann Eshoo (D-California) and Jim Ramstad (R-Minnesota) introduced a bill that they hope will solve the time delay problem and give seniors faster access to new technologies. The Medicare Innovation Responsiveness Act of 2003 is designed to reduce or eliminate delays in the current Medicare coverage, coding and payment processes.

Former senator Bob Dole gave testimony that he said was offered from his current role, that of citizen. "A few years ago doctors discovered I had a condition that my father unfortunately died from," Dole said. "I now have an endograft below my heart and I was able to pay for the device myself. But for seniors who rely on Medicare and can't afford it, the device isn't available due to a sluggish, bureaucratic system that takes too long." Dole added, "Even if the technology is approved by the FDA, it can take months or years for Medicare to cover it."

"We can fix some of the problems with Medicare, but not all, and addressing the payment issue is a difficult, complicated process, but we must provide access to new technology to seniors," said Rep. Nancy Johnson (R-Connecticut), chair of the House Ways and Means Committee, which regulates Medicare. "Medicare needs to be more nimble and responsive to technology. We need to make it modern and aggressive."

Ramstad termed access to medical technology and its newest manifestations "a matter of life and death for seniors and people with disabilities." Ramsted, who serves as co-chair of the House medical technology caucus, said that the federal government "must stop blocking access to life-saving and life-enhancing medical technology. It's time to tear down the barriers that keep seniors and people with disabilities from getting the care they need."

The Medicare Innovation Responsiveness Act of 2003 will require the Centers for Medicare & Medicaid Services (CMS) to:

Establish a Council for Technology and Innovation to improve the timeliness and coordination of coverage, coding and payment decisions.

Implement a policy announced in 2000 to cover clinical trial costs for medical technologies.

Set reasonable deadlines for implementing national coverage, coding and payment decisions, and maintain a strong local coverage process as a vital route to patient access.

Reduce delays of two to four years in the amount of time it takes Medicare to set adequate payment for new medical technologies in the inpatient setting.

Implement reforms, mandated by Congress more than two years ago, to reduce long delays in the Medicare patient appeals process.

Adopt key recommendations from an Institute of Medicine (Washington) report to improve the timeliness of Medicare payment decisions for innovative diagnostic tests.

Eshoo, the other co-chair of the House medical technology caucus and co-sponsor of the bill, said that the proposed legislation represents true reform of the 38-year-old Medicare program. "Today, Medicare patients have to wait 15 months to five years for access to life-saving medical devices that are otherwise readily available to Americans with private health insurance." But, she added, "Some people don't have that much time to wait."

Eshoo said the biggest benefits of the bill are that it would require Medicare to cover costs associated with clinical trials and provide appropriate reimbursement.

"The current CMS position on clinical trials makes it difficult for medical device manufacturers to test the safety and efficacy of new technologies in the senior population," she said, adding, "This bill directs CMS to begin covering these costs immediately."

New office offers 'total life cycle' support

The most challenging aspect of a new office within the FDA is pronouncing it, joked Don St. Pierre, deputy director of the newest regulatory office of the agency. Despite its bulky and unwieldy name, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) within the Center for Devices and Radiological Health is making incremental changes since it was established last November, St. Pierre said.

OIVD's responsibilities and activities were outlined by its management team last month during an FDA-sponsored webcast with senior administrators and industry representatives. The office is a combination of three separate offices that are in turn linked to the FDA's overall strategic plan, explained Steven Gutman, MD, director of OIVD.

"There's no hidden agenda, and we hope that the industry can give us insight on how to make the office work better for them," Gutman said. The philosophy behind the change is to create a total product life cycle for diagnostics, he explained.

The concept makes sense for the FDA to go in this direction, but the concern on the part of the industry is cohesiveness, said Pat Shrader, corporate vice president for regulatory affairs and compliance at BD (Becton Dickinson & Co.; Franklin Lakes, New Jersey). She said, "will this slow us down and will it create too many decision-makers?" Shrader noted that "IVDs are the most challenging devices, especially in the post-market phase, and they are unlike any other device that the FDA regulates, so I commend you on trying this process on the most difficult ones first."

The sentiment was shared by Bill Pignato, vice president of regulatory affairs at Exact Sciences (Maynard, Massachusetts). "My initial reaction is very positive. The total product life cycle concept is familiar to the manufacturing industry. I'm just looking for predictability," he said. Pignato added that the time may be right for revamping the regulatory process related to in vitro diagnostics. "Traditional approaches may not work anymore with the newer diagnostics, such as genetic, molecular and DNA diagnostics, so this might be the perfect opportunity to change."

"The diagnostic area is an exploding technology, and there's no doubt it can ultimately help me, you or a family member, and if we can get the technology to the market faster, then we will be accomplishing one of our goals," Gutman said. "We are certainly open to new things. Nothing's out of limits, so we want the industry to bring ideas to us," he added.

Gutman outlined several initiatives currently under way within OIVD. The most visible accomplishment is the office's web site a new offering on the CDRH site he said. "This is our window to the world and offers details on how IVDs are regulated, [plus] advisory panel information and guidance documents," he said. Office staff also are working to standardize the review process. "We aren't working on a template, but we are creating a checklist," Gutman explained. The office is becoming more transparent as well, he noted. "We will post information and decisions in fostering more communication." OIVD also is working on establishing harmonization among labeling guidelines, he said.

FDA also is establishing communication with the Centers for Medicare & Medicaid Services (CMS; Washington), St. Pierre explained. "CMS has come to our office to give a presentation on what they do, and we've gone to their office as well. We want to be able to help manufacturers start the communication process with CMS as soon as possible."

Shrader commended Gutman and St. Pierre for a "tremendous job" in making manufacturers aware of the "second hurdle" they face following FDA approval: gaining reimbursement from CMS. "Some of the diagnostic companies are very small, and they may not be aware of the additional hurdle of working with CMS to get the device reimbursable," she explained.

OIVD will evaluate its progress by using performance scorecards, which it is developing now, St. Pierre said. "These scorecards will help us determine if we are having an impact," he said. "One of the most difficult things to measure which we will attempt with these scorecards is if our decisions have an impact on public health," Gutman added.

Direct-access testing evolves

The American Association for Clinical Chemistry (AACC; Washington) found that 22% of the 50 sites of clinical laboratory professionals responding to a poll said they were preparing to implement a direct-access testing (DAT) program. DAT makes clinical laboratory testing available to patients without a physician referral. Individuals must pay out-of-pocket for services received in this manner, rather than being reimbursed by an insurer or Medicare, AACC said. Of the 50 responding sites, 35% said that they are in the early stages of considering the implementation of such a program. The poll was conducted during an audioconference presented by AACC titled "Direct Access Testing: Going Beyond Outreach."

"I think that medical systems are still trying to squeeze money out of their expenditures," David Sainato, AACC's manager of professional affairs, said, noting that the initiation of such programs is a way for labs to contribute to the bottom line and to "make up for the way government is not subsidizing the way they used to." Although "the idea for direct-access testing has been around for a couple of decades now," Sainato said, the impetus to start such programs now comes as a result of the fact that the Internet and information systems tools are much more advanced and can move data much more quickly.

There are definite advantages for labs. "It allows [labs] to expand their outreach," Sainato said. "They'll be moving from a clinical to almost a retail environment. It will allow them to [conduct] testing in a population they might not have reached otherwise."

Patients, too, may stand to benefit from such direct-access testing programs. "Some patients are concerned about privacy," Sainato said. "This way they can make sure their results are seen only by them, not by a physician or an HMO representative or an employer." Most people, he said, have access to the healthcare system, "so it may not have that great an impact in terms of access to care," he said.

Potential drawbacks are similar to those experienced by physicians for example, individuals who come in for test results. Someone may be found to be HIV-positive, but then he or she may never return to find out the results. "The laboratory is left holding the bag on that," Sainato said. "It's the limitation of any kind of testing. People may not show up to the physician's [office] to get results."