http://nytimes.com/2002/10/01/national/01DRUG.html


October 1, 2002

Drug Industry Is Told to Stop Gifts to Doctors
By ROBERT PEAR


WASHINGTON, Sept. 30   The government warned pharmaceutical companies
today that they must not offer any financial incentives to doctors,
pharmacists or other health care professionals to prescribe or recommend
particular drugs, or to switch patients from one medicine to another.

The government informed the industry that many practices commonly used
in the marketing and sale of prescription drugs could run afoul of
federal fraud and abuse laws.
Specifically, the government said that drug makers could not offer
incentive payments or other "tangible benefits" to encourage or reward
the prescribing or purchase of particular drugs by doctors, health plans
or companies that manage drug benefits for employers and insurers.

The new standards, the first of their kind, were issued by Janet
Rehnquist, inspector general of the Department of Health and Human
Services, as guidance to the pharmaceutical industry.
Aggressive marketing is the norm in the industry. For years, drug makers
have treated doctors to free Broadway plays, weekend trips, expensive
meals and other lavish perks. Many companies have rewarded middlemen, or
pharmacy benefit managers, for putting their products on lists of
recommended drugs, known as formularies. Some companies have also
rewarded doctors and drugstores for switching patients from one
medication to another.

Similarly, doctors in a position to influence the prescribing of drugs
for large numbers of patients have been retained as advisers and
consultants to drug manufacturers.
While the new standards do not have the force of law, drug makers that
flout them are more likely to be investigated and prosecuted for
violations of federal fraud and kickback statutes.
"In today's environment of increased scrutiny of corporate conduct and
increasingly large expenditures for prescription drugs," Ms. Rehnquist
said, "it is imperative for pharmaceutical manufacturers to establish
and maintain effective compliance programs."

The public will have 60 days to comment on the standards. The government
may revise them in the light of those comments.

The government said it was concerned about the industry's marketing
practices because they could improperly drive up costs for Medicare and
Medicaid, the federal health programs for 75 million people who are
elderly, disabled or poor. The federal government spends $400 billion a
year on the two programs combined, and the cost is expected to double in
10 years.

The new standards say "switching arrangements," under which drug
companies offer financial incentives to shift patients from one drug to
another, "are suspect under the anti-kickback statute."
Similar arrangements, under which companies pay drugstores or pharmacy
benefit managers to contact patients or doctors to encourage them to
change from one drug to another, are also suspect, the government said.
It warned companies that they would run afoul of the law if they
rewarded pharmacies and pharmacy benefit managers for "moving market
share" from one product to another.

The inspector general said that payments to consultants, advisers and
researchers "pose a substantial risk of fraud and abuse" if the payments
exceed "fair market value for the services rendered."

The new guidelines say that drug makers can violate the kickback statute
when they offer entertainment, recreation, travel, meals or similar
benefits; when they sponsor "educational conferences"; and when they
offer research grants, gifts, gratuities and "other business courtesies"
to doctors, hospitals and other health care providers who influence the
prescribing of drugs.
The standards also apply to financial incentives given to purchasing
coalitions that buy drugs and medical devices for hospitals. The buying
groups are sometimes paid by manufacturers whose products they are
supposed to evaluate objectively.

Ms. Rehnquist said that every drug company should appoint a compliance
officer, establish a hotline to receive complaints of fraud and abuse
and consider paying rewards to employees who report misconduct.

Under the new standards, companies are responsible not only for their
own employees, but also for sales agents and contractors who "engage in
improper marketing and promotional activities" on their behalf.

In April, the Pharmaceutical Research and Manufacturers of America, a
trade group for brand-name drug companies, adopted a voluntary marketing
code setting out what sales representatives may do in dealings with
doctors and other health care professionals.

The code says, for example, that a drug maker cannot give golf balls
emblazoned with the company's name to doctors, because the products do
not provide a benefit to patients.

The inspector general said that compliance with the industry code was
desirable, but "will not necessarily protect a manufacturer from
prosecution or liability for illegal conduct."

Employers and health plans hire pharmacy benefit managers to review and
pay claims for prescription drugs, to help control costs and to
coordinate care for patients.

Barrett Toan, chairman of Express Scripts, a pharmacy benefit manager in
St. Louis, said drug makers paid rebates to pharmacy benefit managers
"to make their products more attractive   to improve their position on
the formulary," increasing the likelihood that their drugs will be
prescribed, in preference to products made by other companies.

John M. Rector, senior vice president of the National Community
Pharmacists Association, said, "Pharmacy benefit managers increasingly
take payments from drug makers, with the result that patients are
switched from a product that might be the best prescription drug for
them to a more expensive brand-name product."

The new standards say that drug companies may be subject to civil and
criminal penalties if they report inaccurate or incomplete data on the
prices or sales of their products. The government uses such information
to compute reimbursement under Medicare and Medicaid, and the inspector
general said the reported prices should reflect any discounts or rebates
offered to buyers.
Ms. Rehnquist said that if drug makers found "credible evidence" of
violations of federal law or regulations, they should notify the
government within 60 days, or sooner if beneficiaries could be harmed.

In recent years, the government has issued guidance to other segments of
the health care industry on how to prevent fraud and abuse. Those
guidelines were addressed to doctors, hospitals, nursing homes,
laboratories, home care agencies and suppliers of medical equipment.

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