Financial Relationships Between VHA Health Care Professionals and Industry: - PowerPoint Presentation

Slide1

Financial

Relationships Between VHA Health Care Professionals and Industry:

Training Designed to Help You

U

nderstand the

Requirements

and

Standards in

VHA Handbook 1004.07

Slide2

Introduction

Purpose

This training was designed to help you understand the requirements and standards in VHA Handbook 1004.07: Financial Relationships Between VHA Health Care Professionals and Industry. It was developed to raise awareness among health care professionals about financial relationships and conflicts of interest (COI) and to assist you as a VHA health care professional to understand, avoid, and manage financial relationships with industry that could compromise your professional judgment or the patient’s welfare.

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Introduction

Audience

VHA Handbook 1004.07 applies to all VHA health care professionals whose decisions can influence the range of treatment options available to patients and whose judgment could be biased by relationships with companies that have an interest in VA decision-making.The training is appropriate forphysiciansadvanced practice registered nursespsychologistsphysician assistantspharmacists

other associated health practitioners with prescriptive authority

certain administrators

2Slide4

Introduction

Why you need this training

Research indicates that individuals are often not able to recognize or manage their own conflicts of interest. As noted by Dana and Loewenstein (2003), in situations of conflict of interest, “even when individuals try to be objective, their judgments are subject to an unconscious and intentional self-serving bias”(p. 252). Other researchers have observed that these effects occur even among individuals who are motivated to be impartial and who have been instructed about bias (Orlowski & Wateska, 1992; Chimonas, Brennan, & Rothman, 2007).3Slide5

Introduction

Objectives

The training will help VHA health care professionals understandHow to recognize a financial conflict of interest or a situation that might give the appearance of a conflictWhether they should accept company invitations (e.g. to serve on a pharmaceutical company’s speakers bureau or an offer to be compensated as an author on a paper that supports a manufacturer's product)What a real-time verbal disclosure is, and when it is necessaryHow to manage or avoid financial relationships with industry that create conflicts or that might give the appearance of a conflictKey terms and concepts

In

addition to these topics there is a “Resources” section at the end of this training which includes (1) “Definitions,” (2) “For more information,” and (3) “References.”

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Introduction

How this course is different from training related to government ethics

This training specifically addresses standards related to someone’s role as a health care professional, not to someone’s role as a public servant.This training is not intended to satisfy requirements for training in government ethics. “Government ethics” consists of criminal conflict of interest statutes in 18 U.S.C. Chapter 11 and the Executive Branch Standards of Conduct in 5 C.F.R. Part 2635, which together are commonly referred to as the “government ethics laws” that apply to all employees under the Executive Branch of the federal government. Annual government ethics training can be accessed through the VA Talent Management System at https://www.tms.va.gov/learning/user/login.jsp.

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Introduction

How this course is different from training related to conflicts of interest in research

This training specifically addresses standards related to decisions affecting patient care, not to decisions related to research.This training does not address conflicts of interest in research as identified in VHA Handbook 1200.05: Requirements for the Protection of Human Subjects in Research. For more information about this kind of conflict of interest, please visit the website for the Office of Research and Development: http://www.research.va.gov/resources/policies/default.cfm.

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Conflict of interest (COI)

VHA

Handbook 1004.07 requires that you sign a statement in VetPro, acknowledging your professional responsibilities regarding financial conflicts of interest:“I understand that my professional obligations can be compromised by financial conflicts of interest; therefore, I will avoid conflicts or seek guidance in their management.”How would you define “conflict of interest”?7Slide9

Conflict of Interest

Conflicts

of interest arise when an individual in a position of trust has a financial or other incentive that might compromise the independence of his or her judgment and undermine that trust relationship. Conflicts of interest in health care can undermine the trust of individual patients, as well as public trust in the institution and the medical profession as a whole. 8Slide10

Test your knowledge…

Financial conflict of interest is a key concern addressed in VHA

Handbook 1004.07, Financial Relationships Between VHA Health Care Professionals and Industry. You can find out how much you know about COI and related topics by answering the “Challenge Questions” throughout this module. 9Slide11

Challenge question:

“industry”

Which of the following are examples of “industry” as defined in VHA Handbook 1004.07? Select all that apply.  A. Centers for Disease Control B. Ace Public and Media Relations, serving its client StentcoC. Patients for Sepsis Control, a patient advocacy organization sponsored by the manufacturer of a new antisepsis drugD. Law firm of Smith and Jones, representing ABC Pharmaceuticals

10Slide12

Challenge question:

“industry”

Answer: B, C and D The correct answers are B, C, and D because these are proxies, acting on behalf of companies. 11Slide13

Challenge question:

“financial relationships”

According to VHA Handbook 1004.07, a financial relationship exists between a VHA health care professional and industry in which of the following scenarios? Select all that apply.A. Loan payment from ABC Devices directly to Dr. Smith’s bank in exchange for Dr. Smith’s presentation at ABC Device’s conferenceB. Shares of Science World Pharmaceuticals within Dr. Green’s mutual fundC. Salary for membership on Big Company’s advisory boardD. Payment for being an expert witness for SuperDuper Manufacturing12Slide14

Challenge question:

“financial relationships”

Answer: A, C, DThe correct answers are A, C, and D because they are all examples of compensation made by industry to a VHA health care professional for a service. The answer is not B because a mutual fund is managed by an independent financial firm, not the individual health care professional.13Slide15

Financial relationships with industry that may involve conflicts of interest

Here is a

list of the kinds of industry relationships that may involve conflicts of interest:industry-funded speakers bureausghostwritingindustry-funded advisory boardsindustry-funded publicationsexpert witness testimonyindustry-funded educationgrants or loans from a companypaid role with a company or a company’s proxyMore detailed information about speakers bureaus, advisory boards, and ghostwriting is on the next few slides.

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Challenge question:

How to respond to company invitations

Case Study #1 - Dr. Sara TaylorDr. Sara Taylor, a psychiatrist, meets a friendly sales representative named Ellen from GloboPill, a drug company. While chatting with Ellen, Dr. Taylor reveals that she often prescribes GloboPill's anti-anxiety medication to her VA patients. The next week Ellen invites Dr. Taylor to join GloboPill's speakers bureau and receive $750 an hour to deliver talks to other psychiatrists. Some of the talks would review classes of drugs used to treat anxiety (no brand-names mentioned), and other sessions would specifically promote GloboPill's drug by name. 15Slide17

Challenge question:

How to respond to company invitations

Case Study #1 - Dr. Sara Taylor (continued)What should Dr. Taylor do? A. Accept the offer to deliver general talks but decline to give talks focusing on GloboPill's productB. Decline the offerC. Seek the advice of her supervisor, Service Chief, the Deputy Ethics Official in the Office of General Counsel, or another appropriate officialD. B or C 

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Challenge question:

How to respond to company invitations

Case Study #1 - Dr. Sara Taylor (continued)Answer: DThe correct answer is D. Dr. Taylor should recognize that serving on GloboPill's speakers bureau has the potential to, or could be perceived to, exert inappropriate influence on her professional judgment and decision-making. She should either decline the offer or seek guidance from an appropriate official.A pharmaceutical or device company may have health care professionals on its speakers bureaus because they are more likely than company employees to win the respect and confidence of other health care professionals, especially when the speakers are from well-known institutions. It may not be apparent to audience members that the speaker has been trained to present only certain, positive data

or has a financial

incentive to ignore conflicting studies

.

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Challenge question:

How to respond to company invitations

Case Study #2 – Matthew BarrataMatthew Barrata is the chief technician at a VA hospital. He receives an invitation from ScanCom, a manufacturer of medical imaging machines, to serve on an advisory board. In exchange for advising ScanCom about their products, Matt will receive $2000 per advisory board meeting and in-kind travel expenses.18Slide20

Challenge question:

How to respond to company invitations

Case Study #2 – Matthew Barrata (continued)What should Matthew do? A. Decline the invitationB. Accept the invitation, as well as a similar offer from ScanCom's major competitorC. Seek the advice of his supervisor, Service Chief, the Deputy Ethics Official in the Office of General Counsel, or another appropriate officialD. A or C

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Challenge question:

How to respond to company invitations

Case Study #2 – Matthew Barrata (continued)Answer: DThe correct answer is D. In Matthew's case, he should consider that serving on ScanCom's advisory board has the potential to, or could be perceived to, exert inappropriate influence on his professional decision-making or judgment. He should either decline the offer or seek guidance from an appropriate official.Although some financial relationships between a health care professional and a pharmaceutical or device company can involve legitimate, scientific, or educational goals, others have marketing as their primary goal. Health care professionals may not be aware that, by accepting an invitation to serve on a company’s advisory board, they are participating in the company’s marketing efforts by lending credibility to the company and its products.

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Challenge question:

How to respond to company invitations

GhostwritingReceiving an honorarium for agreeing to be listed as an author on an article authored mostly or entirely by a company or its proxy is a financial conflict of interest as well as a violation of the ethics of authorship. It leads to the erroneous perception that the health care professional was part of a study from the beginning when he or she may have participated only at the end or not at all. Often the identity of the actual author is not disclosed to readers. Some troubling examples of this practice involve health care professionals signing their names to articles when they have not reviewed, or may not even have access to, the original data. This is why medical journals require authors to attest to the role they had in the article.

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Challenge question:

Payments that create COIs

Which of the following payments from industry would create a conflict of interest for a VHA health care professional? A. Compensation for expert witness testimony for a medical device company that does business with VAB. Payment for participating in or attending a company-funded dinner meeting because you are a subject-matter expert who uses the company’s product in VA and are in a position to influence others in VA to use or purchase it C. Compensation by a company for speaking on a company-sponsored educational teleconference to promote the company’s productsD. All of the above

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Challenge question:

Payments that create COIs

Answer: D The correct answer is D. All of the above payments from industry would create a conflict of interest because all of these activities involve a relationship that has the potential to, or can be perceived to, exert inappropriate influence on the integrity of decision-making or your professional judgment in the fulfillment of your obligations to patients. Expert witness testimony, participation in or attending a company-funded meeting, and speaking on a company-sponsored educational teleconference are all activities that are addressed in Handbook 1004.07. Also, note that serving as an expert witness before a Federal agency or court for a party other than the Government, where the United States is a party or has a direct and substantial interest, is generally prohibited by the Standards of Conduct for Executive Branch Employees.

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Challenge question:

“compensation”

Which of the following is an example of “compensation,” as defined in Handbook 1004.07? Select all that apply. A. Dinner provided by an industry-funded Continuing Medical Education (CME) program to Dr. Jones for moderating the programB. Reimbursement of travel costs for speaking at XYZ Manufacturing’s conferenceC. Honorarium for membership on Super Pharmaceuticals’ speakers bureauD. Fruit basket given during the holiday season24Slide26

Challenge question:

“compensation”

Answer: A, B, CThe correct answers are A, B, and C. Dinner, reimbursement of travel costs, and honorarium are all examples of compensation, according to Handbook 1004.07. A fruit basket is considered a gift. Guidance about gifts can be found on the Office of Government Ethics website at http://www.oge.gov/home.aspx and VA’s Office of General Counsel ethics website at https://vaww.ogc.vaco.portal.va.gov/law/ethics/default.aspx.Information on the ethics of gifts to health care professionals can be found in the VHA National Ethics Committee’s report about gifts

to h

ealth

care p

rofessionals

from the p

harmaceutical industry

.

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Challenge question:

“compensation”

Here is a list of the forms of compensation identified in VHA Handbook 1004.07:moneyhonorariaconsulting feeslow-interest loansreal propertyroyaltieslicense feesstock options or other equity interestpaid or reimbursed educationpaid or reimbursed travel and lodging

paid or reimbursed food and beverage

paid or reimbursed entertainment

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Challenge question:

R

eal-time verbal disclosureYou are a VHA committee member who has a financial relationship with industry. What are you required to do according to VHA Handbook 1004.07? A. You must disclose these financial relationships to another committee member who will pass it on, if appropriate.B. You are only required to disclose the financial relationship if compensation exceeds $500.C. You must make a real-time verbal disclosure of these financial relationships to the committee.D. You must disclose the financial relationship in writing to the committee secretary within 90 days of entering into the relationship. 

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Challenge question:

R

eal-time verbal disclosureAnswer: CThe correct answer is C. You must make a real-time verbal disclosure of financial relationships to the committee.If you are a member of a VHA decision-making or advisory group, you have a responsibility to make a real-time verbal disclosure of any financial relationships you have with industry that may have a bearing on the work of the group. The goal of the required real-time verbal disclosure process is to bring to light any financial relationships that

members

may have with individual

companies that may potentially bias their judgment or the work of the group. Disclosures should be made before deliberation and decision-making.

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Challenge question:

R

eal-time verbal disclosureCase Study #3 - Dr. Evan JonesEvan Jones is a well-respected orthopedic surgeon. In the last twelve months and before coming to VA he received $9000 for participating in three educational events funded by Best Drug & Device Co. Dr. Jones has just been appointed to serve on the Clinical Logistics committee which focuses on the type of device that was included in the educational program.

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Challenge question:

R

eal-time verbal disclosure Case Study #3 - Dr. Evan Jones (continued)What should Dr. Jones do to comply with real-time disclosure requirements?30Slide32

Challenge question:

R

eal-time verbal disclosureCase Study #3 - Dr. Evan Jones (continued)Dr. Jones should ask himself,“Am I receiving compensation from industry?”Here, again, are examples of compensation

:

money

honorariaconsulting fees

low-interest loans

real property

royalties

license fees

stock options or other equity interest

paid or reimbursed education

paid or reimbursed travel and lodging

paid or reimbursed food and beverage

paid or reimbursed

entertainment

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Challenge question:

R

eal-time verbal disclosureCase Study #3 - Dr. Evan Jones (continued)Dr. Jones should ask himself, “Am I on a VHA group that requires that I provide real-time verbal disclosure of my financial relationships?”

Members of these groups are required to provide

real-time

verbal disclosure of their financial relationships:

Medical Advisory Panel (MAP)

VISN Pharmacist Executives

VISN Formulary Committees

P & T Committees

Field Advisory Committees

VA/DoD Evidence-Based Practice Work Group

Clinical Logistics

Procurement

Technology Assessment

National Leadership Council (NLC)

NLC standing committees

VISN-level Executive Leadership Board

Additional decision-making or advisory groups as determined by VISN Directors or the Principal Deputy Under Secretary for Health

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Challenge question:

R

eal-time verbal disclosure Case Study #3 - Dr. Evan Jones (continued)What should Dr. Jones do to comply with real-time disclosure requirements? A. Disclose that Best Drug & Device Co. funded his participation in the educational events.B. Disclose that he has no financial relationships because the payments were for educational work performed off VA property.C. Disclose that he has no financial relationships because the payments fall below the monetary threshold for disclosure.

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Challenge question:

R

eal-time verbal disclosureCase Study #3 - Dr. Evan Jones (continued)Answer: AThe correct answer is A. Health care professionals who serve on VHA decision-making and advisory groups are responsible for disclosing their financial relationships with industry that are relevant to the issues or companies that the work of the committee addresses. There is no monetary threshold for the real-time verbal disclosure requirement, and the financial relationship exists regardless of where the educational event occurred.Health care professionals who serve on VHA decision-making and advisory groups must identify financial relationships that occurred in the previous twelve months. Also, they must disclose any interviews or negotiations for employment with any entity that might be relevant to the work of the group. Although it is not required, financial relationships that ended more than twelve months ago may be disclosed if you think this relationship may have a bearing on the work of the group.

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Real-time verbal disclosure and confidentiality

As

part of the real-time disclosure process, colleagues should respect each others’ confidentiality and not share information about a colleague’s disclosures outside the group.35Slide37

Challenge question:

Avoiding a potential COI

What questions should health care professionals consider if they are offered monetary or in-kind payments or gifts from industry? Select all that apply. A. Does the payment or gift have the potential to compromise my professional judgment?B. Are the financial incentives so good that they outweigh the risk of a potential COI?C. Does the arrangement potentially undermine public trust in health care professionals or the VA?D. Is the payment or gift compatible with VHA policies and government ethics laws?

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Challenge question:

Avoiding a potential COI

Answer: A, C, and D The correct answers are A, C, and D. All questions should be considered except for the following: “B. Are the financial incentives so good that they outweigh the risk of a potential COI?” Although many people believe that compensation from industry, free meals, and small gifts do not influence their decisions and recommendations, research shows that “there are systematic and predictable ways in which people act unethically that are beyond their own awareness” (AAMC, 2007, p.2). Judgment is affected by unconscious and unintentional self-serving bias even when individuals try to be objective. In her article “Industry Gifts to Healthcare Providers: Are the Concerns Serious?” Lisa Day, RN, CNS, PhD cites the anthropological literature on gift-giving as a form of exchange. With the act of accepting a gift comes the obligation and impulse to return the gift. Accepting a gift creates an unwanted debt for the receiver. “In this sense, there is no such thing as a ‘no strings attached’ gift, since the very nature of the gift carries the obligation to reciprocate. Healthcare professionals should be encouraged to refuse all gifts from industry no matter how seemingly inconsequential” (Day, 2006, p. 512).

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Challenge question:

Managing financial relationships

What step(s) should you, a health care professional, take to ensure that financial relationships with industry do not undermine patient care at VA facilities? A. I should recognize that financial relationships with industry have the potential to compromise my professional judgment.B. I should disclose my financial relationships with industry as part of my service on specific VHA decision-making or advisory groups.C. I should bring any concerns about the industry relationships of other health care professionals to the relevant supervisor or official, or facility leadership.

D. I should avoid

financial

relationships with industry or seek guidance in managing them.E. All of the above

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Challenge question:

Managing financial relationships

Answer: E All of these are correct. Health care professionals should be aware that financial relationships with industry can influence their professional decision-making. For this reason, they should avoid or seek guidance in managing offers from industry, and they should disclose their industry relationships to chairpersons of decision-making groups on which they serve.If a health care professional is concerned about a colleague's or a superior's financial relationship, the health care professional should bring that information to the appropriate authority. Depending on the situation, it may be best to discuss this matter with the person who has the potentially inappropriate relationship. You may bring the matter to his or her attention, encouraging him or her to address the problem. If this approach does not work, or if there is some reason for you to believe that this person would not be receptive to your suggestion, you may have to bring your concern to the health care professional's supervisor, appointing official, or facility

leadership.

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Challenge question:

The difference between government ethics and professional ethics

Select all of the statements that are true. Government ethics and professional ethics are the same.Government ethics and professional ethics are different. Making a real-time verbal disclosure meets the same requirement as filling out a Form 450 “Confidential Financial Disclosure Report.”An item that has a monetary value of $15 can compromise professional judgement.

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Challenge question:

The difference between government ethics and professional ethics

Answer: B and DThe correct answers are B and D. Although government ethics rules may allow you to accept or do some things, it may be inappropriate for you to accept or do these same things in your role as a health care professional. Handbook 1004.07 requires real-time verbal disclosure because health care professionals have an obligation to put the interests of patients first. The disclosure requirements behind Form 450 are based on the obligations of public servants.

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End of Training

Congratulations, you've completed the course. You have learned

how to manage or avoid financial relationships that create conflictsyour responsibilities regarding real-time verbal disclosure requirementskey concepts and termsPlease feel free to review the “Resources” section on the next few slides which includes (1) “Definitions,” (2) “For more information,” and (3) “References.” 42Slide44

Resources

Definitions

The following key concepts are defined in VHA Handbook 1004.07: Financial Relationships Between VHA Health Care Professionals and Industry: Financial relationship – any arrangement between an individual VHA health care professional and pharmaceutical; biotechnology; medical device; product; equipment; and technology companies or their proxy medical education or public relations firms. Financial relationships also include relationships with disease advocacy groups; or law firms that involve monetary or in-kind compensation to the health care professional or non-profit entities that directly or indirectly support the health care professional in ways such as salary, honorarium, consultation fee, or reimbursement; or financial holdings in pharmaceutical, biotechnology, medical device, product, equipment, and technology companies. (

Click here to return to slide 4 – Introduction

)

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Resources

Definitions (continued)

Industry– includes pharmaceutical companies, biotechnology companies, medical device, product, equipment, and technology companies, and proxy medical education, publishing, public relations firms, disease advocacy groups, and law firms working on behalf of such companies. (Click here to return to slide 4 – Introduction) Financial Conflict of Interest – a financial relationship that has the potential to, or could be perceived to, exert inappropriate influence on the integrity of decision-making or the professional judgment of health care professionals in the fulfillment of their obligations to patients, and thus damage public trust. (Click here to return to slide 7 - Conflict of interest (COI))

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Resources

Definitions (continued)

Compensation – includes money or other transfers of value, including consulting fees, honoraria, low-interest loans, real property, royalties, license fees, stock options or other equity interest, paid or reimbursed education, paid or reimbursed travel and lodging, paid or reimbursed food and beverage, paid or reimbursed entertainment. (The list is repeated on slide 26 and 31.)Click here to return to slide 26 - Conflict of interest (COI)Decision-making or Advisory Group – any group, such as a working group, advisory committee, task force, board, or committee that makes (1) decisions on clinical or technical requirements for major purchasing decisions, or (2) recommendations that would have significant implications for major purchasing decisions, or (3) major purchasing decisions. Click here to return to slide 28 - Test your knowledge: Real-time verbal disclosure

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Resources

Definitions (continued)

Health Care Professional (HCP) – a VHA health care professional is any full-time, part-time, or without-compensation (WOC) employee of, or trainee in, VHA who makes treatment recommendations that pertain to commercial products or who is involved in making formulary decisions, developing clinical practice guidelines, institutional policies on care, or in other activities within the health care system that can have a significant effect on the range of treatment options available to patients. These may include physicians, advanced practice nurses, psychologists, physician assistants, pharmacists, other associated health practitioners with prescriptive authority, and certain administrators. Click here to return to slide 4 - Introduction46Slide48

Resources

For more information

An FAQ document, sample scripts for real-time verbal disclosure, a link to the policy, and other materials related to Handbook 1004.07: Financial Relationships Between VHA Health Care Professionals and Industry can be found on the National Center for Ethics in Health Care website: http://vaww.ethics.va.gov/activities/policy.aspGuidance about gifts, conflicting financial interest, impartiality, misuse of position, outside activities, and financial disclosure can be found on the Office of Government Ethics website at

http://www.oge.gov/home.aspx

and VA’s Office of General Counsel ethics w

ebsite at https://vaww.ogc.vaco.portal.va.gov/law/ethics/default.aspx

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Resources

For more information

For more information about this training or Handbook 1004.07: Financial Relationships Between VHA Health Care Professionals and Industry, contact the National Center for Ethics in Health Care at vhaethics@va.gov.For more information about conflicts of interest in research as identified in VHA Handbook 1200.05: Requirements for the Protection of Human Subjects in Research, access the Office of Research and Development website: http://www.research.va.gov/resources/policies/default.cfm

.

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Resources

References

Association of American Medical Colleges (2007). The scientific basis of influence and reciprocity: A symposium. Retrieved from https://members.aamc.org/eweb/upload/The%20Scientific%20Basis%20of%20Influence.pdfChimonas, S., Brennan, T. A., & Rothman, D. J. (2007). Physicians and drug representatives: Exploring the dynamics of the relationship. The Journal of General Internal Medicine, 22(2), 184-190. Retrieved from

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1824740/

Dana, J. & Loewenstein, G. (2003). A social science perspective on gifts to physicians from industry.

The

Journal of

the American

Medical

Association, 290

(2).Retrieved

from

http

://jama.jamanetwork.com/article.aspx?articleid=196871

Day

, L. (2006). Industry gifts to healthcare providers: Are the concerns serious?

American Journal of

Critical Care

, 15(5). Retrieved

from

http://

ajcc.aacnjournals.org/content/15/5/510.long

Orlowski

, J. P. & Wateska, L. (1992

). The

effects of pharmaceutical firm enticements on physician

prescribing patterns

.

Chest (102)

, 270-273. doi:10.1378/chest.102.1.270

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