Physicians say that, slowly, surely, they are being forced out of the Medicare program and heading for greener pastures, a process that creates a severe barrier to healthcare for America's seniors. The American Medical Association (AMA; Chicago, Illinois) issued that as a warning call last month with its release of results of an online survey concluding that Medicare payment cuts to physicians, nurses and other health professionals also directly impact seniors."Physicians want to serve America's seniors, but they simply cannot afford to accept an unlimited number of new Medicare patients into their practices while facing continued payment cuts," said the AMA's immediate past president, Richard Corlin, MD. According to the survey, he said, "24% of physicians have either placed limits on the number of Medicare patients they treat or plan to institute limits in the next six months due to sharp Medicare payment cuts."

Before the summer recess, the U.S. House passed legislation providing for a 6% increase in physician Medicare payments over three years. But the Senate failed to act on similar legislation before the recess, and the AMA is lobbying for Senate action before the session ends in October.The increase passed by the House will result in 2005 payment rates that are 20% higher than if no increases had been proposed, said the AMA. The legislation would add $21.3 billion to Medicare spending on physician and provider services over five years. The proposed increases would take effect Nov. 1, provided the Senate passes similar legislation.

Following are other findings from the survey:

92% of physicians said they signed or continued an agreement to participate in the Medicare program for 2002, but only 83% plan to participate in 2003.

53% of physicians have in the last six months or plan within the next 12 months to defer equipment purchases.

21% of physicians plan to lay off staff in the next 12 months.

51% of physicians said the decision to make a change in their practice in the next 12 months is influenced by the 5.4% Medicare payment cut.

The AMA said the survey, conducted earlier this year, represents nearly 2,000 responses.

Lowest bid not best for CMS, say senators

The lowest bid may not always be the best for the Centers for Medicare & Medicaid Services (CMS), Sen. Mary Landrieu (D-Louisiana) said in a warning issued to lawmakers in mid-September. In a news conference called to voice resistance to Medicare's new proposal for competitive bidding, Landrieu, a vocal opponent of that initiative, was joined by Sen. Max Cleland (D-Georgia) in raising a variety of objections. "My experience as a former state treasurer has taught me that in some instances, the lowest bid may not always be the best in terms of quality," Landrieu said. "The demonstration projects done by CMS do not show any evidence of lower costs and improved benefits," she added. "Therefore I must oppose any legislative efforts undertaken here toward those goals."

The Senate is poised to take up H.R. 4954 — the piece of legislation containing the competitive bidding language — before the mid-term election recess. Known as the Medicare Modernization and Prescription Drug Act, the legislation containing a national competitive bidding program falls under section 511 of the bill.

Landrieu's sentiments, suggesting that quality might be compromised when price is the determining factor, were echoed by Peter Thomas, co-chair of the newly-formed Consortium of Citizens with Disabilities Health Task Force (Alexandria, Virginia) and the Coalition for Access to Medical Services, Equipment and Technology (also Alexandria), known as CAMSET. CAMSET was formed by a number of consumer, trade and advocacy organizations expressing concern that expanding competitive bidding from the current two demonstration projects to a national policy is premature. The policy, CAMSET contends, would undermine the quality of care, restrict patients' choices of suppliers and service providers, and stifle new technology development. Even further, it argued, it could drive suppliers, especially the smaller firms, out of business.

Thomas said that creating a competitive bidding program also would discourage existing participation among the nation's hospitals and physicians, and many Medicare beneficiaries would have to select a new provider. "Should Congress pass legislation that allows competitive bidding to take place, we will in effect have a second tier of providers. There is no current 'Class B' set of hospitals and physicians, but that's what this will create," Thomas said.

This legislation not only affects durable medical equipment, which includes wheelchairs and oxygen and other inhalation drugs, but also would range to off-the-shelf orthotic devices covered under part B Medicare, he explained.

"If Congress intends to focus on cutting costs," Thomas asked, "why does the competitive bidding principle stop at durable medical equipment? Why not extend it further into the physical therapy, physician office and hospital areas as well?"

He added, "I wonder where our country will be in 10 years if Congress passes this? I would suggest that by then Medicare will be controlled by large supply companies. The small ones will have been driven out years earlier."

Other adverse results of the bill cited by CAMSET would be additional layers of bureaucracy. The Secretary of the Department of Health and Human Services, for example, would be given the additional authority to develop quality and financial standards for contracts awarded.

Total amounts paid under the contract, including administrative costs, would be required to be lower than the total amounts that would otherwise be paid, according to CAMSET and other critics of the plan. They point to the legislative language that says the secretary would be required to re-bid the contracts every three years and can limit the number of contractors in a competitive area to "the number necessary to meet product demand."

FDA puts homecare devices under 'scope

Reimbursement — perhaps the largest obstacle facing device manufacturers in the hospital setting — will likely rear its rather ugly head again in the home health environment, according to panelists and attendees at the recent meeting titled, "Medical Devices in the Home Healthcare Community," sponsored by the FDA's Center for Devices and Radiological Health and held at the National Institutes of Health campus in Bethesda, Maryland. While meeting topics included standards in design, certification and education, the reimbursement topic repeatedly surfaced.

During public comment periods, attendees said that though new technologies can be adapted to home health use, they likely will face inadequate or absent reimbursement from the Centers for Medicare & Medicaid Services (CMS). "What I've heard here over the past two days is that CMS is the elephant in the living room. The regulations are rigid in their application despite the influx of new technology," said meeting facilitator Joe Arcarese of the Food and Drug Law Institute (Washington).

"There was no mention here of what's in the pipeline in terms of innovative technology. I didn't hear anything about how wireless technology can be used in home health. Plus, if there's no methodology for reimbursement, the technology will likely not follow," attendee Ron Kelly of Motorola (Schaumburg, Illinois) told the panel.

Representatives from CMS acknowledged the reimbursement issues, but said they were only following procedures established by Congress.

Another hot topic for both manufacturers and healthcare providers was the safety and maintenance of medical devices in the home. Traditionally, devices were used in the hospital under physician or nurse supervision. Increasingly, devices are migrating into the home health environment where patients and family caregivers are operating them. "What's needed is for the government and manufacturers to get back to basics and educate home health staff on how to use the devices correctly in the home," Arcarese said.

Educating both staff and home health patients about the use of a device has taken a top priority within the Department of Veterans Affairs (VA). The agency reports development of a risk model in which patients and their family caregivers are assessed, and if they are seem largely unable to use a device correctly, a home health provider gives the patient and family more intense training and monitors their progress more closely, explained Janine Purcell, cognitive engineer at the National Center for Patient Safety at the Veterans Health Administration (Ann Arbor, Michigan).

Mary Brady, executive secretary for the FDA's home health panel, said that the agency could not face the issue of migrating medical devices into the home without help. "This is a huge, complex issue and we need everyone's help," she said. "We need to update the definition of what home is; for many, it may not be the same as what we think in terms of home."

West Nile adds to tissue, blood concerns

The human tissue and blood bank industries, already under heavy scrutiny to avoid the transmission of infections via their products, will be subject to even closer analysis following last month's determination that a deceased Georgia woman and three recipients of her donated organs were infected with West Nile virus. The Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) confirmed the West Nile infections in the donor and three of the four people who received some of her organs following her early-August death as the result of an auto accident.

The CDC has not yet unraveled a key puzzle related to this confirmation: whether the organ donor's infection was the result of the transfused blood received while being treated for her injuries, or the result of her being bitten by a mosquito. However, late last month, the agency gave broad confirmation to the possibility that the virus can be transmitted by human blood. Overall, the consensus of public health officials is that the risk of transfusion-transmitted infections is too low to avoid need transfusions of blood. However, that consensus is being counterbalanced by increasing caution concerning the nation's blood supplies. That concern was underlined recently with the issuance of an FDA alert warning blood banks to carefully screen out donors with even mild symptoms signaling potential infection.