FEES
TO DOCTORS BY DRUG MAKERS TO BE DISCLOSED |
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A NEW U.S. REGULATION | |
By ROBERT PEAR | |
TUESDAY, JANUARY 17, 2012 | |
WASHINGTON — To head off medical conflicts of interest, the Obama administration
is poised to require drug companies to disclose the payments they make
to doctors for research, consulting, speaking, travel and entertainment. |
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Many
researchers have found evidence that such payments can influence doctors’
treatment decisions and contribute to higher costs by encouraging the
use of more expensive drugs and medical devices. |
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Consumer advocates and members of Congress say patients
may benefit from the new standards, being issued by the government under
the new health care law. Officials said the disclosures increased the
likelihood that doctors would make decisions in the best interests of
patients, without regard to the doctors’ financial interests. |
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Large numbers of doctors receive payments from drug
and device companies every year — sometimes into the hundreds of thousands
or millions of dollars — in exchange for providing advice and giving lectures.
Analyses by The New York Times and others have found that about a quarter
of doctors take cash payments from drug or device makers and that nearly
two-thirds accept routine gifts of food, including lunch for staff members
and dinner for themselves. |
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The
Times has found that doctors who take money from drug makers often practice
medicine differently from those who do not and that they are more willing
to prescribe drugs in risky and unapproved ways, such as prescribing powerful
antipsychotic medicines for children. |
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Under
the new standards, if a company has just one product covered by Medicare
or Medicaid, it will have to disclose all its payments to doctors other
than its own employees. The federal government will post the payment data
on a Web site where it will be available to the public. |
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Manufacturers
of prescription drugs and devices will have to report if they pay a doctor
to help develop, assess and promote new products — or if, for example,
a pharmaceutical sales agent delivers $25 worth of bagels and coffee to
a doctor’s office for a meeting. Royalty payments to doctors, for inventions
or discoveries, and payments to teaching hospitals for research or other
activities will also have to be reported. |
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The
Obama administration estimates that more than 1,100 drug, device and medical
supply companies will have to file reports, generating “large amounts
of new data.” Federal officials said they would inspect and audit drug
company records to make sure the reports were accurate and complete. |
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Companies
will be subject to a penalty up to $10,000 for each payment they fail
to report. A company that knowingly fails to report payments will be subject
to a penalty up to $100,000 for each violation, up to a total of $1 million
a year. |
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Top
executives are potentially liable because a senior official of each company
— the chief executive, chief financial officer or chief compliance officer
— must attest to the accuracy of each report. |
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The
new requirements, or something very similar, will take effect soon; in
fact, they are overdue. Under the new health care law, the administration
was supposed to establish payment-reporting procedures by Oct. 1, 2011.
The public will have until Feb. 17 to comment on the proposals, which
are broadly consistent with the expectations of industry and consumer
groups. After considering the comments, Medicare officials will issue
final rules with the force of law. |
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Consumer
advocates have long demanded details of the financial ties between doctors
and drug and device companies. |
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Allan
J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts,
said: “Patients want to know they are getting treatment based on medical
evidence, not a lunch or a financial relationship. They want to know if
their doctor has a financial relationship with a pharmaceutical company,
but they are often uncomfortable asking the doctor directly.” |
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In
an introduction to the proposed rules, the Obama administration says that
patients can benefit when doctors and the industry work together to develop
life-saving drugs and devices. But, it said, these relationships can also
“lead to conflicts of interests that may affect clinical decision-making”
and “threaten the underlying integrity of the health care system.” |
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The
administration does not try to define the difference between proper and
improper payments. It says simply that public reporting of the financial
ties between doctors and drug and device companies “will permit patients
to make better-informed decisions when choosing health care professionals
and making treatment decisions.” |
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The
new standards carry out legislation championed by Senators Charles E.
Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The
legislation was included in the 2010 health care overhaul. |
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“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said. | |
Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers. | |
“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said. | |
Matthew D. Bennett, a senior vice president of the Pharmaceutical Research and Manufacturers of America, said the industry “supported transparency of physician payment information.” However, he said, it is important that payment data be presented in a proper context, emphasizing that interactions between doctors and drug companies played a critical role in improving care, educating doctors and fostering appropriate use of medicines. | |
Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices. | |
Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing. | |
The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks. | |
The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery. | |
Comment: |
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An Obama administration decision that I agree on.... Woooooo! | |
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