Lasik Eyes Surgery - ACPE Sounds Alarm Over Medtech Business Practices

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ACPE Sounds Alarm Over Medtech Business Practices

gospa68@aol.com

2005-04-08, 10:25 pm

ACPE Survey Sounds Alarm over Medtech Business Practices

In an era when corporate behavior is widely suspect, it isn't
surprising that companies in the healthcare sector have been subjected
to scrutiny on many fronts. So far, federal prosecutors have not
considered it necessary to investigate the business practices of the
medical device industry on a broad scale. But if the attitudes of
physician executives are any indication, that could change-and soon.

In a recent survey by the American college of Physician Executives
(ACPE; Tampa, FL), 79% of respondents said that they were very or
moderately concerned about physicians being influenced by medical
device companies to perform a certain procedure. That level of alarm
was second only to concern over physicians who refuse patients without
insurance (80%), and was even greater than respondents' concern over
the influence of pharmaceutical companies (76%).

Among respondents to the ACPE survey, 63% also said that they were very
or moderately concerned about physicians being paid to make promotional
pitches for vendors. And 66% said that they were very or moderately
concerned about nonphysician executives accepting gifts from vendors.

ACPE's Kolb: Teaching leaders.
Nearly 1500 U.S. physician executives participated in the survey, which
was published as part of a special report in the March/April issue of
The Physician Executive: Journal of Medical Management. "The survey
results show us a serious problem facing U.S. healthcare," said ACPE
president Marvin O. Kolb, MD. "Our challenge at ACPE and other
professional organizations is to teach healthcare leaders how to
identify and eliminate unethical business practices and behaviors."

Release of ACPE's survey results came hard on the heels of a session
at the annual meeting of industry association AdvaMed (Washington, DC),
in which speakers cautioned that federal prosecutors have already begun
to take a closer look at business practices in the medical device
industry. Companies are being investigated for practices that violate
federal fraud and abuse statutes, with emphasis on activities that
bring sales and marketing personnel in direct contact with healthcare
professionals.

McAnaney: Warning industry.
Speaking at the AdvaMed meeting, Washington, DC, attorney Kevin G.
McAnaney said that investigators' interest in medical device
companies follows years of similar investigations targeting hospitals,
clinical laboratories, and pharmaceutical manufacturers. Now, he warned
attendees, device companies have become targets because "they're
the only people left who've got any money." McAnaney is a
nationally recognized expert on healthcare fraud and abuse who served
as chief of the industry guidance branch in the office of counsel to
the inspector general from 1997 to 2003. His private practice focuses
on healthcare fraud and abuse matters, including compliance reviews,
transactional work, and civil and administrative litigation.

According to McAnaney, the number of fraud and abuse cases involving
medical device companies is increasing largely because whistleblowers
have begun to identify suspect company practices. Once prosecutors have
identified a particular violation at one company, it is typical for
them to investigate other companies for the same violation. "If
prosecutors find evidence that a suspect practice is widespread in the
industry, they will quickly expand their investigations to other
companies," McAnaney said. "They'll try to run the table."

AdvaMed has been actively seeking to avoid giving prosecutors such an
excuse. The AdvaMed session presented the preliminary results of a
"Compliance Benchmarking Survey" undertaken to measure the extent
to which medical device companies are implementing the code of ethics
put into effect by AdvaMed in January 2004. Intended for industrywide
adoption, the code establishes policies to guide interactions among
medical device companies and healthcare providers, especially with
regard to sales and promotional activities.

Presenting the results was Brian Salsberg, associate principal in the
business-consulting firm of McKinsey & Co. (Washington, DC), which
conducted the confidential survey among AdvaMed member companies. The
law firm of King & Spalding (Washington, DC) also contributed to the
design and analysis of the survey.

Although only 48 companies responded to the survey, they included both
large and small companies with a variety of corporate structures; 23%
of the responding companies were based outside the United States. Key
findings of the survey included the following.

=B7 Among responding companies, 92% were aware of the AdvaMed code of
ethics.
=B7 Most of the responding companies are modifying corporate policies
in response to the requirements of the code.
=B7 Training about the code is being provided to employees, including
sales reps (88% of responding companies), marketing personnel (85%),
and senior executives (83%).

Not surprisingly, companies with greater annual revenues tend to have
more formal ethics compliance functions than their small-company
counterparts. Among the survey respondents, companies with a formal
compliance function or officer had average revenues of more than $1.7
billion, while those without such a function had average annual
revenues of $40 million. Staffing of the function also differs
according to company size: large companies maintain an average
compliance staff of 7.2 permanent and 5.5 part-time employees, while
small companies have an average of 2.2 permanent and 0.2 part-time
employees. Both large and small companies supplement their in-house
compliance staffing through the use of temporary contractors.

According to Salsberg, tracking compliance with the AdvaMed code is a
major challenge for medical device companies. The majority of companies
responding to the survey (55%) said that they currently have few or no
formal key performance indicators with which to measure their
compliance. Salsberg recommended that companies develop in-house
surveys that can be used to measure compliance over time.

Apparently, considering the results of ACPE's recent survey, not
everyone agrees that industry's implementation of the AdvaMed code of
ethics has been effective. But perhaps the perception of wrongdoing
exceeds reality. Despite the strong concern expressed by 79% of the
respondents to ACPE's survey, only 7.8% of the respondents identified
device company influence as the most-frequent ethical challenge in
their own institutions-less than half the percentage reporting undue
influence from pharmaceutical companies (19.7%).

A summary of the ACPE survey results is available from the
organization's Web site at www.acpe.org/ethicalsurvey. A summary of
the AdvaMed "Compliance Benchmarking Survey" is available via the
AdvaMed Web site at
www.advamed.org/publicdocs/compliancepresentation.pdf.

CatmanX

2005-04-11, 6:14 pm

One solution is to teach physicians to use their brains and learn to
diagnose correctly in the first place. THe reason they reach for
medical devices is that they allow faster, easier treatment. Why don't
they treat those without insurance? Probably because the equipment
costs a lot and they are not into free treatments.

We are now in an age of entrepreneurial medicine whether we like it or
not.

serebel

2005-04-11, 6:14 pm

I don't know how it works per se down under, but we here in the US have
the trial lawyers to blame for this.

SErebel

CatmanX

2005-04-11, 6:14 pm

Actually, the public is to blame, trial lawyers are just a response to
a public that wants to blame someone else for all their woes. We had a
gynaecologist sued for $100,000 last year after a woman got pregnant
after tubal ligation. She instructed the gyny that one tube was blocked
off and only one needed to be tied. He did this. It seems that the
blocked one wasn't and it was determined that the gyny was to blame for
her pregnancy. She did love the child she said, but why should she pay
for the upbringing of a child she never planned for?????

It is the same with RS, poor outcomes want to sue the ophthal because
they are not happy. As much as some RS surgeons are a little trigger
happy with their lasers, and every patient is seen as a perfect
candidate, I know of none who don't try their best for a perfect result
every time.

serebel

2005-04-11, 6:14 pm

Yeah the public does hold a huge responsibility, but you should see
some of the trial lawyer ads here. Caching, caching, let the cash
register ring! Anything you do in life is someone elses fault and you
are entitled to money. It's sickening here in the US.

SErebel