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Article Date: 9/1/2002

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A Guide To Ethics in 2002 and Beyond
Recent laws and guidelines provide a blueprint for how optometrists and industry reps can maintain the highest standards.
BY JIM THOMAS, EXECUTIVE EDITOR

On a typical day, in this case, August 8, 2002, the headlines in the New York Times read:

  • "Students Use Web Sites to Cheat on Graduate Exams"
  • "Ex-Drug Executive Faces Charges of Insider Trading"
  • "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.

Missing 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).

"Optometrists practice with the highest of ethical standards," he says. "The AOA has always supported ethical practices, and we support the new industry guidelines."

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.

The 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 right prescription

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. Interactions should inform doctors about products, science and/or education that benefit patients.

Presentations. 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.

Continuing 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 all attendees.

Consultants. 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.

Speaker 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.

Educational funds. Financial assistance for scholarship or educational funds is permitted as long as an academic or training institution independently selects the recipients.

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.

Representatives should offer nothing that would interfere with the independence of a professional's prescribing practices.

AMA

The 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.

A few gray areas in the code require independent judgments. Some of these include:

Charitable 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.

Contributions to professional societies from industry. These could appear to affect the judgment of a physician.

Gift 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.

Accumulating points by attending several educational or promotional meetings. These are acceptable if the points do not result in substantial gifts.

Compensation 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.

By the book

The AOA states its position on gifts and compensation to optometrists in resolution 1886:

"The 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."

In 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.

"Some 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 patients."

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 practitioner.

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."

Federal law

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.

The 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.

The 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 years.

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 government).

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.

Federal guidance

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.

The 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.

 

Resources for Ethical Behavior

Listed below are selected resources that may provide guidance with ethical and legal codes relative to gifts and remuneration from manufacturers.

The PhRMA Code

(www.phrma.org/press/newsreleases//2002-04-19.390.phtml)

This 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."

AMA Guidelines for Gifts

(http://www.ama-assn.org/ama/pub/category/5689.html)

This 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.

The Anti-Kickback Statute

(http://oig.hhs.gov/fraud/docs/safeharborregulations/072991.htm

This document summarizes the Medicare Anti-Kickback Statute and specifies various payment practices that are protected from criminal prosecution or civil sanctions.

The Civil False Claims Act

(http://www.usdoj.gov:80/04foia/readingrooms/chcm.htm)

The Department of Justice memo to attorneys provides guidance for the use of the False Claims Act in civil healthcare matters.

Prescription Drug Marketing Act

(http://www.usdoj.gov/usao/eousa/foia_reading_room/usam/title4/civ00113.htm)

The Department of Justice Attorneys' Civil Resource Manual summarizes the PDMA and includes a sample indictment and a list of exemptions.

Fraud Detection and Prevention

(http://www.oig.hhs.gov/fraud/complianceguidance.html#2)

This reference on the Health and Human Services Web site provides information and guidelines on HHS initiatives to prevent fraud in the healthcare industry.

An Optometrist's Guide to Clinical Ethics

Yes, the 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

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