Medical Device Daily Washington Editor

WASHINGTON – The Federal Communications Commission (FCC) has published a notice of inquiry seeking feedback from the healthcare industry on the use of radio frequency (RF) communication inside and outside of hospitals.

The cover sheet accompanying the July 18 notice said the FCC would coordinate with the FDA “to help address the issues surrounding wireless technology in and around medical devices and systems.”

The full notice says that the FCC “intends to modify its rules to accommodate the development and use of a variety of new medical devices that rely on radio [frequency] communication for critical aspects of their functionality” due to the “pace and nature of development of newer, more capable and more sophisticated devices [which] may be inadequately covered by these rules.”

The commission said that there will be “following generations of medical devices with which we are not yet adequately familiar and whose needs should be taken into consideration to the extent that they can be anticipated.”

The approach to rule-making will encompass “certain modifications to our rules to better accommodate new medical devices immediately and imminently available,” which is said to entail the allocation of two megahertz of spectrum for use by implanted and body-worn medical device radio transmitting devices.”

Among other considerations, the FCC is looking for input “on whether implanted medical devices that rely on inductive signal coupling should be permitted to operate in the 90-110 kHz band.”

Another area of interest is how the FCC might address “the challenging array of RF-spectrum sharing issues . . . including the protection of user health and safety when implants receive interference from primary allocated services in the band.”

Initial comments must be submitted to the FCC by Oct. 31; the deadline for reply comments is Dec. 4.

The FDA issued a statement encouraging all of those in healthcare using radio communications to respond to the FCC's Notice of Inquiry, saying that it “presents a unique opportunity to provide information to the FCC to help formulate future telecommunications plans and actions.”

The agency said that the information received by the FCC “will be coordinated with FDA to help address the issues surrounding wireless technology in and around medical devices and systems.”

'Overburdened' emergency care examined

The House Ways and Means Committee's subcommittee for health recently held a hearing on the state of emergency health services in the U.S. and got an earful from those inside the system.

The hearing, chaired by Nancy Johnson (R-Connecticut), was populated by references to a recent report by the Institute of Medicine (IOM; Washington), which charged that emergency care in the U.S. “as a whole is overburdened, underfunded and highly fragmented,” leaving it “ill-prepared to handle surges from disasters such as hurricanes, bombings, or disease outbreaks.”

Larry Bedard, senior partner at California Emergency Physicians (Emeryville), thanked Rep. Pete Stark (D-California) for introducing the Emergency Medical Treatment and Active Labor Act (EMTALA), passed into law in 1986. Bedard noted that prior to EMTALA, “the only people who had a legal right to healthcare were prisoners.”

On the other hand, that first iteration of EMTALA needed work, he said.

According to Bedard, the law defined a responsible physician as one who was employed or had a contract with a hospital, which conflicted with a law in California that prohibited hospitals from employing physicians. The state of California managed to amend that problem, followed by an impasse created by the fact that many specialists “refuse to take call[s], citing EMTALA's unfunded mandates and threats of significant fines.”

Bedard added that in 2005, “nearly three-quarters of emergency department [ED] medical directors indicated that they had a problem with on-call backup” from physician specialists.

The recent report published by IOM, titled “Hospital-Based Emergency Care: At the Breaking Point,” also came up in Bedard's testimony.

“I want to congratulate the IOM's Committee on the “Future of Emergency Care” . . . for a comprehensive, thought-provoking report,” Bedard said, adding that “I agree with virtually all of their key findings.”

He lauded the notion of regionalization of care (which would force ambulances to deliver patients only to hospitals staffed and equipped to deal with their emergency), but he pointed out that when such a system was proposed in California in the late 1980s, legal counsel advised the authorizing bodies that “regionalizing emergency care may violate federal antitrust laws.”

Bedard urged Congress to amend such laws to “expressly permit competing hospitals and healthcare systems to regionalize emergency care.” He said that the IOM notion of accountability could be addressed if “we proactively audited and enforced the EMTALA rules, regulations and interpretive guidelines,” which are currently “only reactively enforced.”

He said: “Isn't it a little strange that when 73% of emergency department medical directors have problems with on-call coverage there are only a handful of EMTALA investigations?”

However, Bedard took exception to the IOM recommendation that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois) accredit and certify emergency systems, arguing that the IOM report indicated that JCAHO had backed away from standards it had set for hospitals on emergency care and that “in some respects, having JCAHO regulate the emergency care system is like having the proverbial fox guard the henhouse.”

However, he seconded the IOM suggestion of pay-for-performance for Medicare and Medicaid services as an incentive to improving efficiency and stated that regionalization might take some of the pressure off the on-call specialty dilemma.

Bedard also complained about “the [liability insurance] costs of being an emergency physician . . . or an on-call specialist.”

He recommended that Congress examine the Access to Emergency Medical Services Act of 2006 (H.R. 3875), authored by Rep. Bart Gordon (D-Tennessee) as a means of knocking down this disincentive.

Frederick Blum, president of the American College of Emergency Physicians (ACEP; Dallas, Texas), reported to the committee that ACEP's National Report Card on the State of Emergency Medicine gave “80% of the country . . . mediocre or near-failing grades, and America earned a C-, barely above a D.”

On the subject of ED overcrowding, Blum commented that the level I trauma center where he works is “so overcrowded that people are waiting up to 11 hours to be seen.”

Another factor in the emergency room pinch is “the differences in payer mix,” which Blum stated has a “substantial impact on a hospital's financial condition.” Sixteen percent of those who show up in emergency rooms are uninsured, according to Blum, and another 37% are on Medicare, Medicaid or a state children's health insurance program (SCHIP).

“According to an American Hospital Association (AHA; Chicago) statement from 2002, 73% of hospitals lose money providing emergency care to Medicaid patients while another 58% lose money for care provided to Medicare patients,” Blum said. Undocumented aliens add another $1.45 billion to the hospital tab.

Blum offered several recommendations, including the expansion of emergency department space and protocols that would distribute ED loads across the hospital. He also said that “lawmakers should enact universal health insurance that includes benefits for primary care services.”