As the U.S. Department of Justice examines the selling practices of cardiovascular companies, large and small – one of the smaller being Ela Medical (Cedex, France) – the potential to find certain payments to physicians illegal isn’t going unnoticed by the medical device industry. In the two years since the Advanced Medical Technology Association (AdvaMed: Washington) released it voluntary code of ethics, the association’s membership has bought into the code in increasing numbers.

In a press statement following the conclusion of the Medical Device Regulatory and Compliance Congress (March 29-31) at Harvard University (Cambridge, Massachusetts), the law firm King & Spalding (Atlanta) reported “a 100% adoption rate of the AdvaMed code.” The statement also asserted that nine of 10 companies “apply the code to all company professionals, regardless of their title or seniority.” Those numbers are up since the publication of a AdvaMed press release in March in which the association reported the results of a benchmarking survey, said to have shown that “the vast majority (85% or more) of firms had policies in place relating to consulting arrangements with and gifts to healthcare professionals, provision of reimbursement and technical information, and company sales and promotional meetings.” More than half the compliance officers surveyed report directly to their firms’ CEOs and more than three of four responding firms “have trained their most relevant employees,” including sales personnel.

The AdvaMed code of ethics is based on a compliance program guide published by the Office of Inspector General at HHS in May 2003. In that notice, HHS stated that the purpose of its guide was to “encourage the use of internal controls to efficiently monitor adherence to applicable statutes, regulations and program requirements.” While the guidelines explicitly address pharmaceutical firms, the document also states that the “guidance may also have application to manufacturers of other products that may be reimbursed by federal health care programs, such as medical devices and infant nutritional products.” HHS cautioned that the guidance “should not be viewed as mandatory or as an exclusive discussion” of compliance program elements, but recommended that even those firms with existing programs may want to use the HHS program “as a benchmark or comparison.”

AdvaMed officially ratified its code in January 2004, after the board of directors gave the document its stamp of approval the previous September. The association states in the preamble that the members are aware that ethical standards “are critical to the medical device industry’s ability to continue its collaboration with health care professionals.” However, the association also points out that its code “is intended to facilitate ethical behavior and is not intended to be, nor should it be, construed as legal advice.”

The guidance states that the selection of healthcare professionals as consultants should be based on “the consultant’s qualifications and expertise” rather than on “the basis of volume or value of business generated by the consultant.” It also recommends that with the exception of educational models or books, “any gift from a member should have a fair market value of $100 or less.” But the voluntary program does not appear to be backed by the threat of sanctions.

Christopher White, AdvaMed’s general counsel, told Biomedical Business & Technology that while the association has no formal mechanism for dealing with firms that are demonstrably out of compliance with the association’s code, “we encourage our members and the public to contact the compliance officers of companies if they suspect non-compliant activity.” White noted that AdvaMed has a list of compliance officers for member companies on the association web site and that “I have had about four or five calls that I directed to company compliance officers.”

Abbott Laboratories (Abbott Park, Illinois) has come up with one of the more novel approaches to reinforcing its code of conduct. As reported in the October 2004 edition of CRM Magazine, Abbott put together a touch-screen video game titled “Rocked or Shocked,” a game that provides users with a refresher course in the company’s ethical guidelines. In Rocked or Shocked, the protagonist, Joe Salesguy, flashes a grin at every correct answer, but when the user misses the answer, Joe “receives a nasty charge.”

Catherine Sazdanoff, vice president of compliance and ethics at Abbott Labs’ Ross Products division, said that the company wanted to “have something live and fresh” as a way of engaging employees, and they have “responded really well to this.” However, the firm does not keep track of scores.

Devices peripheral in critical path?

The FDA’s Critical Path Initiative, or CPI, may do wonders for new drug development, but its impact on the number of medical device and diagnostics developed and approved is less certain. The agency’s March publication of the Critical Path Opportunities Report detailed the areas where the agency hopes to see substantial progress in the near term, but devices and diagnostics seem destined to play a somewhat peripheral role.

According to the Critical Path FAQ on the agency’s web site, product development is currently based on tools that are “badly outdated,” which calls for an upgrade of four elements of product evaluation, namely animal models of human disease, biomarkers of physiological reaction to therapeutic efforts, clinical trial design and quality assessment technology. The FDA insists its aim is not to take “sole responsibility” for nudging industry down this path, but that it is taking the lead because “it is the only entity capable of creating the focus necessary for this task.”

Biomarkers is one emphasis of the agency’s Critical Path initiative and one where devices overlap into the diagnostics sector. According to an agency press statement concerning the initiative, the FDA is pinning much of its hopes on “a new generation of predictive biomarkers [that] would dramatically improve the efficiency of product development” and identify safety problems prior to marketing. In that release, the FDA’s Deputy Commissioner of Operations Janet Woodcock, MD, who also is the director of the CPI, added that another aim of the CPI is “development of new types of clinical trials that will produce better data faster.”

Firms in the cardiovascular market may find encouragement in a discussion of improved trials and data development stemming from the FDA’s interest in “a statistical model for qualifying late loss in lumen diameter as a surrogate measure for drug eluting stent trials.” Biomarkers that indicate cardiovascular disease are also an area of the agency’s interest.

Makers of imaging technologies and agents were not left out. Performance standards for novel imaging displays were mentioned in the report, as were the use of medical imaging to assist in product development and in detection of markers in several classes of disease states, including heart disease, arthritis, neurocognitive disorders and cancer.

The agency also expressed a keen interest in development of computerized modeling of device performance that would require the corollary development of a “rigorous model of specific aspects of human physiology,” especially for pediatric applications.

Richard Frank, MD, PhD, vice president of clinical and medical strategy for GE Healthcare (Waukesha, Wisconsin), said in an e-mail response to BB&T that while the effort to boost the use of biomarkers for drug development may feed demand for existing diagnostic and imaging technology, the resulting demand would most likely be “small, relative to clinical use,” and that “the effort necessary to support such applications is greater because pharmaceutical and biologics innovators always want a customized approach to accommodate their specific product.”

Gas container guidelines issued

The FDA last month issued a proposed rule designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas. The agency said that in some cases, injury or death has resulted from medical gas mix-ups such as mistaken administration of industrial gas to patients, improper connection of industrial gases to medical oxygen supply systems, and contamination of medical gas cylinders with residues of industrial cleaning solvents.

The agency said that it has received reports of at least eight deaths and 18 serious injuries as a result of medical gas mix-ups between 1996 and 2006. “By issuing this proposal, FDA is heightening consumer and industry awareness about this specialty area of regulated products. Greater understanding of the possible problems associated with the use of medical gases and the steps we can take to eliminate them will only lead to safer use of these products,” said Steven Galson, MD, director of the Center for Drug Evaluation and Research.

The regulation would apply to medical gas manufacturers and distributors and will require that certain portable medical gas containers comply with the following requirements:

• outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
• identification by labels that wrap all the way around the tops of the containers;
• painting of high-pressure medical gas cylinders according to a standard color-coding system that corresponds to the gases stored in them;
• and dedication to medical use and not converted to industrial use.

The FDA said that besides a “careful evaluation” of the operations and processes required to produce suitable medical gases, the agency has conducted several public meetings to gather comments from the medical gas industry, patients, professional associations and manufacturers.

Additionally, it said that the Joint Commission on Accreditation of Healthcare Organizations and the National Fire Protection Association have taken steps to help prevent medical gas mix-ups and ensure the safe use of medical gases. There is a 90-day public comment period on the proposed regulation before the FDA develops the final rule.

Hospitalization for complications on rise

The number of patients admitted by U.S. hospitals to treat complications resulting from surgery or medical treatment increased from 305,000 in 1993 to 452,000 in 2003, according to data released in March by the Agency for Healthcare Research and Quality (AHRQ; Washington), a unit of the Department of Health and Human Services. Complications from surgery can include postoperative infections. Complications from medical care can result from extended bed rest and may include lung embolism, dangerously low blood pressure or collapsed lung.

The number of cases of surgical or medical care complications admitted through hospital emergency departments rose from 98,000 in 1993 (32% of all cases) to 211,000 (47% of all cases) in 2003. The average cost to hospitals for treating surgical or medical complications increased from $6,840 in 1993 to $9,600 in 2003.

The statistics come from the Nationwide Inpatient Sample, part of AHRQ’s Healthcare Cost and Utilization Project. This project comprises a family of databases and related software tools developed through a federal/state/industry partnership and sponsored by AHRQ. HCUP includes the largest set of publicly available databases on all patients in the U.S., regardless of type of insurance or whether the patients had insurance.

U.S. ‘appropriate’ care doesn’t equal tech

While the U.S. can boast about its leadership in producing the most advanced medical technology in the world, that leadership doesn’t translate to the best medical care, according to a report published recently in the New England Journal of Medicine, U.S. residents receive “appropriate” medical care about 55% of the time, regardless of race, income, education or health insurance status, according to a study published.

For the study, funded by the Robert Wood Johnson Foundation, researchers at RAND examined data collected through telephone interviews and medical records from a 6,712 adults in 12 communities between 1998 and 2000, using 439 accepted standards to evaluate the quality of care that participants received for 30 chronic and acute medical conditions and for disease prevention.

Participants, the study authors judged, received appropriate medical care 54.9% of the time. Black participants received appropriate medical care 57.6% of the time, compared with 57.5% for Latino participants and 54.1% for white participants. The study also found that female respondents received appropriate medical care 57% of the time, compared to 52% for males. Participants with annual incomes of more than $50,000 received appropriate medical care 57% of the time, and those with annual incomes of less than $15,000 received appropriate medical care 53% of the time. In addition, the study found that participants without health insurance received appropriate medical care 54% of the time, compared with 55% for those enrolled in managed care plans.

According to the study authors, the U.S. healthcare system should provide appropriate medical care 80% to 90% of the time. Steven Asch, lead author of the study and senior natural scientist at RAND Health, said, “Not only is no place safe – no one is safe from poor quality. No matter what group we looked at, whether they were black, white, rich or poor, uninsured, insured, educated, uneducated, all of them were receiving mediocre care.”

Hagel forms healthcare commission

Sen. Chuck Hagel (R-Nebraska) has formed a commission of healthcare experts to develop health care reform recommendations for federal legislation, according to a report by the Omaha World-Herald. The commission is made up of 10 members who will examine healthcare access and quality, cost control, the roles of medical science and technology to improve care, and the effect that baby boomers will have on future costs, according to the newspaper. Part of the commission’s mandate is identifying “more effective financing vehicles for American healthcare than current public and private plans.”

Hagel said that the goal would be to ensure sustainable healthcare for all families. Chuck Marr, founding CEO of Alegent Health (Omaha), will serve as chair of the commission. “Having accessible, affordable and quality healthcare is the desire of every American,” Marr said.

Hagel said, “As medical technologies advance and our population ages, healthcare will become increasingly important to maintaining America’s competitive position in the world.” He asked the committee to submit its recommendations after one year of study.

Bill tackles women’s heart disease, stroke

A group of women lawmakers, described as bipartisan in makeup, has introduced a bill (S. 2278) that would require health information currently reported to the federal government to specify gender to improve efforts to prevent heart disease and stroke among women, according to a report by CQ HealthBeat.

The HEART for Women Act would call for annual recommendations to Congress on efforts to improve the treatment of heart disease and eliminate disparities in care. In addition, the legislation would make available in all 50 states for a program by the Centers for Disease Control and Prevention (Atlanta) that provides heart disease and stroke tests to low-income, uninsured women at no cost. The program currently is available in 14 states.

Sen. Debbie Stabenow (D-Michigan), co-sponsor of the bill, said, “We all have to stop thinking of heart disease as a ‘man’s disease’ and start insisting on improvements in the prevention, diagnosis and treatment of heart disease among women.”

Supporters of the legislation include the American Heart Association, the American Stroke Association, the National Coalition for Women with Heart Disease and the Association of Black Cardiologists.

Panel: Insurers favor costly back treatments

Insurance companies favor fusion surgery over back pain management therapies, according to a recent panel of orthopedic surgeons, interventional radiologists, physiatrists, and pain management specialists from leading academic centers nationwide. Yet fusion surgery often is more than 10 times costlier than other methods of managing chronic discogenic lower back pain. The panel discussed and examined pain management strategies from medical specialties that routinely work with patients suffering from chronic lower back pain.

The panel was conducted by MedPanel (Cambridge, Massachusetts), an online medical market research company that convenes online physician panels to gain insights into various healthcare and clinical issues. The discussion was sponsored by the American Society of Interventional Pain Physicians (ASIPP; Paducah, Kentucky) and Smith & Nephew Endoscopy (Andover, Massachusetts).

In discussing their treatment options for patients with chronic discogenic lower back pain, panelists agreed that the first course of treatment should always be physical therapy and/or chiropractic, muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs). If the patient doesn't respond to these treatments in four to six weeks, most of the panelists agreed that minimally invasive procedures should be considered. Panelists also agree that the last treatment to consider is fusion surgery, which fuses two or more damaged discs together, reducing or eliminating pain, but can also cause potential complications such as nerve damage and treatment failure.

The panel of physicians concluded that there is a bias toward the higher-cost fusion surgery option. This bias is the result of several factors -- in particular, insurance companies opting to pay for more invasive treatments, rather than minimally invasive or pain management procedures, even though those pain management protocols and procedures are considerably less expensive and may be more clinically relevant.

David Kloth, MD, president of ASIPP and an interventional pain physician at Danbury Hospital (Danbury, Connecticut) expressed surprise that private insurers are so willing to reimburse fusion surgeries, which can run anywhere from $50,000 to $70,000, depending on how many levels of the spine are fused. "For years, surgeons have done these big back operations with very little proof and evidence that they really do anything," he told Biomedical Business & Technology. "Yet, the surgeons do 200,000 [lumbar fusions] a year." He said that so far there have been no good randomized controlled studies to determine how effective these lumbar fusion procedures are. And while Kloth said some of these procedures are indicated, many are not.

A 1999 study in the Journal of the American Medical Association titled, "Avoiding the Unintended Consequences of the Growth in Medical Care," bears out these findings, as do market data, according to the physicians panel. The study found that while many believed that more medical care must lead to improved health and well-being, this thinking also has led to more expensive surgical procedures.

By comparison, a considerably less expensive, but effective and less-invasive procedure called intradiscal electrothermal therapy (IDET) costs about $7,000, but only between 5,000 and 7,000 of these procedures are performed each year.

IDET is sold by Smith & Nephew Endoscopy, but the procedure has not caught on despite the fact that it is substantially less expensive, less invasive and reversible, unlike a fusion surgery. S&N's IDET procedure is for those who have failed a program of aggressive non-operative therapy. During the procedure, controlled levels of thermal heat are applied to the affected disc to contract and thicken the collagen fibers within the disc wall, potentially closing the cracks and tears and cauterizing the tiny nerve endings that cause the pain.

Initially, Kloth said that perhaps some minimally invasive techniques such as IDET were first done on patients that perhaps were not good candidates for the procedures, but over the last six or seven years, "we've certainly refined [the population] and it's much better." He defined a "good" candidate for IDET as someone with good disc height (70% or greater), no instability, no significant modic endplate changes and no sizeable disc herneations

Kloth said he believes that patients should definitely get a second opinion before having a fusion done, adding that he thinks insurance companies, who are known for their desire to keep costs to a minimum, will come around to the notion that trying out the less-costly alternative first might be better for the bottom line. "I think what you're going to see five years from now are the insurance companies are actually going to mandate a pain-management evaluation before you have a lumbar fusion," he said.