Advanced Medical Technology Association (AdvaMed; Washington) President and CEO Stephen Ubl said early last month that the World Trade Organization’s (WTO) proposal to eliminate tariffs imposed on the trade of medicines and medical devices “is the most effective means to improve global health standards.”

The joint proposal by U.S., Singapore and Switzerland calls for eliminating tariffs and non-tariff barriers to trade as part of the WTO’s non-agriculture market access agenda.

AdvaMed noted that some medical devices are subject to tariffs in the 10% to 15% range and can be as high as 30%. The organization said tariffs pose “a significant barrier to the adoption and use of these lifesaving and life-enriching technologies.”

According to statistics gathered by the United Nations, $23 billion in medical technology and almost $33 billion in pharmaceuticals trade is subject to import tariffs, predominantly by developing countries.

AdvaMed said recent studies by the World Health Organization (Geneva, Switzerland) and the AEI-Brookings Joint Center “confirm the need for countries grappling with severe public health crisis to remove import tariffs on medicines and medical devices.”

In a statement, Ubl said, “The WTO proposal will help ensure that patients worldwide, especially those who live in developing countries and have the greatest need for medical care, will have access to critical medicines and medical technologies.”

He noted that AdvaMed has supported policies that facilitate trade for medical technologies dating back to the previous Uruguay round of negotiations.

FDA issues final bed guidance

After 21 years – and reports of 413 deaths – the FDA last month unveiled its final guidance on hospital bed design intended to reduce the occurrence of hospital bed entrapments. In unveiling the guidance, the agency said that over those 21 years – from Jan. 1, 1985, to Jan. 1, 2006 – it had received reports of 691 entrapments in hospital beds. Of these 691 incidents, there were 413 deaths, 120 injuries and 158 “near-miss events.” The near-misses resulted in no serious injuries because there had been some intervention to prevent them.

Most of the entrapments involved strangulation, the result of the neck being caught under, in or between bed rails, the neck or chest being caught between the bed rails and mattresses, under bed rails, between split rails, or between the bed rails and the head or foot boards. Some appeared to be the result of being smothered by being trapped in these openings. It said that the entrapments occurred in various settings: hospitals, nursing homes and private homes, and that most of the entrapments occurred in long-term care facilities.

Larry Kessler, director of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and Radiological Health, characterized the total number of deaths, injuries and near-misses as appearing “small,” but said the agency “believes[s] they are signals about significant adverse events.” But he also suggested there has been significant under-reporting of such events. “Often adverse events such as these go unreported to the FDA, making it likely our counts of these tragic adverse incidents is lower than the number that actually occurs,” Kessler said.

The guidance says that those at greatest risk are elderly patients, “especially those who are frail, confused, restless, or who have uncontrollable body movement, are most vulnerable to entrapment.”

This guidance, “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment,” was developed, the FDA said, with the use of input from both government and private-sector groups. It identifies special issues associated with hospital bed systems and provides design recommendations for manufacturers of new hospital beds and suggestions for healthcare facilities on ways to determine any risks of entrapment for existing beds.

The terms “recommendations” and “suggestions” are key, since the guidelines are not mandatory. And it specifies various limitations. The “dimensional limits,” it says, “may not reduce entrapments in all populations,” such as pediatrics and the developmentally disabled.

The bed systems that are covered include manual patient transfer devices, manual adjustable hospital beds, hydraulic adjustable hospital beds, AC-powered adjustable hospital beds, wheeled stretchers labeled for extended-stay use; power patient rotation beds, power patient transport systems labeled for extended-stay use, powered wheeled stretchers labeled for extended-stay use, manual patient rotation beds and powered flotation therapy beds.

The guidance characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, recommends dimensional criteria for new hospital bed systems, provides information about reporting entrapment adverse events, and includes a description of recommended test methods for assessing gaps in hospital bed systems.

Kessler said that the guidance is intended to “assist individuals, families and healthcare facilities in making better informed decisions to ensure a safe sleeping environment for people who need these beds. While not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment, this new guidance will help ensure that new hospital beds are designed to reduce the potential for entrapment” and entrapment risks identified. He said it could also be used “as part of a manufacturer’s or facility’s comprehensive bed safety program.”

Societies protest dollars cutbacks for imaging

A letter signed by some 30 medical societies, technology associations, healthcare providers and patient advocates has asked congressional leaders to reconsider the cuts made in medical imaging services for Medicare beneficiaries in the Deficit Reduction Omnibus Reconciliation Act of 2005. Among other points, the letter said Section 5102 of the act, “would significantly cut Medicare reimbursement for the provision of diagnostic and interventional imaging services.” It added: “These life-saving diagnostic services are performed by a wide array of physician specialties in their offices and in freestanding imaging centers. This provision singles out imaging services to absorb over one-third of all the Medicare payment reductions in the DRA.”

Sent to House and Senate leaders, the letter said: “We are particularly concerned that these cuts were included without any public deliberation by either body of the Congress. There has been no analysis of the potential impact of this change in payment policy, and we fear that these cuts will have numerous unintended consequences, including potentially diminishing access to imaging services outside the hospital setting.” It added: “We ask that you work with us and the committees of jurisdiction on this issue to fix this new provision in the law prior to its implementation in January 2007.”

The letter was sent by the National Electrical Manufacturers Association (Rosslyn, Virginia), with the other groups signing it representing more than 75,000 physicians and tens of thousands of individuals.

The signers of the letter included the Academy of Radiology Research, Academy of Molecular Imaging, American College of Radiation Oncology, American College of Radiology, American Society for Therapeutic Radiology and Oncology, Society for Vascular surgery, Society of Interventional Radiology and Society of Nuclear Medicine.

Among the other groups was the Advanced Medical Technology Association (Washington).

Homecare group raps recommended freeze

The American Association for Homecare (AAHomecare; Alexandria, Virginia) has questioned the recommendation in the Medicare Payment Advisory Commission’s (MedPAC) “March 2006 Report to Congress” to freeze Medicare payment rates in 2007 for the nation’s 7,300 home health agencies. The organization said the proposed cut, if enacted by Congress, would come on top of negative marketbasket updates for home health agencies in each of the last five years.

“For MedPAC to suggest anything that continues to undercut the financial underpinnings of the home health benefit is simply beyond the pale at a time when the first wave of the baby boomers will begin retiring in the next 18 months and will be depending on Medicare,” said Sue Mairena, chief operating officer of AAHomecare. She added “Simply put, the freeze is unwarranted, unjust and unsound.”

AAHomecare said it believes that the MedPAC home health freeze recommendation is based on two “critically flawed” assumptions – distorted margin data and overstated sector growth.

On the former, the association said MedPAC “continues to base its annual update recommendation on only part of the homecare sector by excluding all hospital-based home health agencies.” Yet, it said in a statement that hospital-based agencies represent a full 25% of the total sector, according to data from the Centers for Medicare & Medicaid Services (CMS; Baltimore).

AAHomecare said that similarly, MedPAC gives “disproportionate weight” to large home health agencies (HHAs) with higher profit margins through utilization of a weighted methodology rather than a method that gives equal weight to all providers. “There is no statistically sound reason for either of these actions on the part of MedPAC,” the association said in its statement.

As for overstated sector growth, the group said, “one of the principal underpinnings of MedPAC’s recommendation for a freeze in the payment rate is the recent growth in the number of Medicare home health agencies nationwide.”

The organization said that between 2003 and 2004 the total number of home health agencies grew by a net total of about 335, “representing growth of less than 5% nationally.” But virtually all of that growth, it said, came from two states, Florida and Texas, together accounting for 395 new agencies.

AAHomecare said 28 states saw a decline in the number of HHAs, seven had no change, and the remaining 15 had “fractional” increases. AAHomecare said “the great majority of Medicare beneficiaries choose to receive care at home when possible, and said it “will continue to work with the Congress to prevent future cuts to this critical Medicare benefit.”