Guide To Ethics in 2002 and Beyond
Recent laws and guidelines provide a
blueprint for how optometrists and industry reps can maintain the highest
BY JIM THOMAS, EXECUTIVE EDITOR
a typical day, in this case, August 8, 2002, the headlines in the New York Times
- "Students Use Web Sites to Cheat on
- "Ex-Drug Executive Faces Charges of
- "Malicious Intent Evident in Recent
Arrests in Texas."
PHOTO BY PAT SIMIONE
Unethical and questionable practices appear to
reach across every institution and industry, including healthcare. Last October,
for example, TAP Pharmaceutical Products agreed to pay $875 million to resolve
criminal charges and civil liabilities in connection with fraudulent drug
pricing and marketing conduct. The prosecution, which included a guilty plea
from a physician, resulted in the largest criminal and civil recoveries in any
healthcare fraud case in the country.
from the headlines is the mention of questionable practices by optometrists.
This is no accident, says Pat Cummings, O.D., F.A.A.O., president of the
American Optometric Association (AOA).
practice with the highest of ethical standards," he says. "The AOA has
always supported ethical practices, and we support the new industry
Industry observers warn,
however, that temptation is never far away. One key to maintaining good conduct,
ethically and legally, is to understand the current laws and ethical guidelines.
guidelines that refer to gifts and compensation, summarized below, come from a
variety of sources, including those listed in the box at the right.
The PhRMA voluntary
code regarding interaction with healthcare professionals outlines how sales and
marketing representatives should interact with all health professionals.
Effective in July, the code addresses the following points:
Interactions should inform doctors about products, science and/or education that
They can include modest meals (by local standards) that are conducive to
presentations. Meals with spouses or without a company representative are
inappropriate, as are entertainment and recreational events.
education and professional meetings. Financial support is permissible;
however, it should be given directly to the meeting sponsor, which can reduce
the fee for all.
Companies should exercise
no control over content, venue, faculty, educational methods or materials.
Financial support should not be offered to non-faculty. Support can be provided
to the meeting's sponsor for modestly priced meals or receptions that benefit
Compensation is appropriate for healthcare professionals who act as consultants
on behalf of a pharmaceutical manufacturer provided that:
- A written contract specifies nature and
payment of services.
- A legitimate need for the service is
identified in advance.
- The criteria for selecting consultants is
directly related to the identified purpose.
- The number of consultants isn't greater than
the number needed to achieve the purpose.
- The retaining company makes appropriate use of
the consultant's services.
- The consulting services are the primary focus
of the meeting.
It's inappropriate to pay honoraria or expenses
to non-faculty or non-consultant attendees at company-sponsored meetings.
training. It's appropriate to reasonably compensate healthcare professionals
for company-sponsored events if they receive extensive training that will result
in service to the company.
funds. Financial assistance for scholarship or educational funds is
permitted as long as an academic or training institution independently selects
Items for personal
benefit should never be offered. Items may be offered to healthcare
professionals if they aren't substantial in value ($100 or less) and if they
benefit the patient.
For example, a
textbook involves a patient benefit; a CD player does not. Items of minimal
value (pens, etc.) may be offered if they benefit the practice. Payments --
including cash or expenses -- should never be offered except as compensation for
bona fide services.
offer nothing that would interfere with the independence of a professional's
major drug manufacturers, including those not represented by PhRMA, have adopted
codes for marketing and sales reps. These are all consistent with guidelines
that the AMA created in 1990 for physicians.
few gray areas in the code require independent judgments. Some of these include:
contributions on behalf of the physician. These may also represent a
personal benefit to the physician. If the charity is predetermined without the
physician's input, there appears to be little problem.
to professional societies from industry. These could appear to affect the
judgment of a physician.
certificates. These are acceptable if they allow the physician to choose
from: 1) patient care items that are of unsubstantial value or 2) practice items
of minimal value. The certificate should not give the recipient such control as
to make the gift similar to cash.
points by attending several educational or promotional meetings. These are
acceptable if the points do not result in substantial gifts.
for visits to industry facilities. If the physician provides genuine
services, reasonable compensation is acceptable. If a company insists on an
educational visit for protection from liability for improper usage, physicians
must use their own judgment. In this case, no honoraria would be appropriate.
The AOA states its position on
gifts and compensation to optometrists in resolution 1886:
American Optometric Association opposes any prescribing and/or dispensing of
ophthalmic products based on the participation by the eyecare provider in a
manufacturer's advertising and/or promotional program involving the prospect of
personal inducements to the eye care provider from the manufacturer."
the book An Optometrist's Guide to Clinical Ethics, Thomas F. Dorrity, O.D.,
chair of the AOA's Ethics and Values Committee, and R. Norman Bailey, O.D.,
discuss issues related to manufacturer incentives.
manufacturers may offer optometrists financial incentives to use their devices
or prescribe their products," they write. "Such a commitment to a
manufacturer may lead to unnecessary intervention or preclude recommending a
superior option for a patient's needs, even if it results in no harm to
AOA published the book in
2000 and distributed it to AOA members and colleges of optometry. (It's now out
of print.) The book provides insights and a decision-making process to guide the
In their chapter, Drs.
Dorrity and Bailey remind optometrists that "The AOA Code of Ethics
instructs optometrists to keep the visual welfare of patients uppermost, to
enhance continuously their education and technical proficiencies to the end that
patients shall receive the benefits of all acknowledged improvements in visual
care, and to conduct themselves as exemplary citizens."
Three federal laws address
healthcare fraud and abuse. Enacted in 1988, the Prescription Drug Marketing Act
prohibits anyone from knowingly selling, purchasing, trading or offering to
sell, purchase or trade a prescription drug sample.
statute also prohibits the resale of any prescription drug that was previously
purchased by a hospital or other healthcare entity. Exempted are wholesale
distributors or retail pharmacies licensed under the state.
Medicare Anti-Kickback Statute provides criminal penalties for individuals or
entities that knowingly or willfully offer, pay, solicit or receive remuneration
to induce business reimbursed under the Medicare or state healthcare programs.
The offense is punishable by fines of up to $25,000 and imprisonment of up to 5
The Civil False Claims Act prohibits
submission for payment of a claim that's known to be fraudulent. It also
prohibits the use of false or incomplete records, or of reverse false claims
(records used to conceal, decrease or avoid an obligation to the federal
While many fraud laws apply to
claims made to Medicare and Medicaid, the Health Insurance Portability and
Accountability Act (HIPAA) creates five new offenses (healthcare fraud,
embezzlement/theft, false claims, obstruction and money laundering) which may be
prosecuted under the federal criminal statutes if any healthcare benefit is
applied for under any public or private plan or contract.
The Health and Human Services
Office of Inspector General (OIG) will publish compliance guidelines for the
pharmaceutical industry later this year. The OIG has already released guidelines
for eight healthcare industry sectors.The guidance is not mandatory or
all-inclusive; it's intended to to prevent improper conduct.
straight and narrow
You can use other
resources to understand ethical behavior. The Internet displays thousands of
pertinent Web sites and chat rooms. Professors at colleges of optometry
specialize in ethics.
However, despite the
guidance offered, the responsibility to address questionable practices
ultimately rests with each individual optometrist.
for Ethical Behavior
below are selected resources that may provide guidance with ethical and
legal codes relative to gifts and remuneration from manufacturers.
press release includes a link to the new code on interactions between
pharmaceutical manufacturers and healthcare professionals. It also
features a link to a brief code "backgrounder."
Guidelines for Gifts
Web site is intended to help educate physicians and industry
representatives about ethical guidelines regarding gifts that are given to
physicians from industry as a part of marketing practices.
document summarizes the Medicare Anti-Kickback Statute and specifies
various payment practices that are protected from criminal prosecution or
The Civil False
Department of Justice memo to attorneys provides guidance for the use of
the False Claims Act in civil healthcare matters.
Drug Marketing Act
Department of Justice Attorneys' Civil Resource Manual summarizes the PDMA
and includes a sample indictment and a list of exemptions.
Detection and Prevention
reference on the Health and Human Services Web site provides information
and guidelines on HHS initiatives to prevent fraud in the healthcare
An Optometrist's Guide
to Clinical Ethics
book is out of print, but used copies do surface for sale on the Internet.
For example, at press time two copies were available at www.half.ebay.com.
Optometric Management, Issue: September 2002