Category Archives: Conflicts of Interest

USPSTF on PSA Testing for Prostate Cancer


The US Preventive Services Task Force published their final recommendation update on PSA screening to detect early prostate cancer.  The USPSTF is the most unbiased and science-based organization in the US.  It is free from bias, and scrupulously maintains a strict conflict of interest policy.  It’s members do not have a financial interest in the outcome of the analyses done, like the American Urological Association might have for PSA testing, nor do they have a conflict of commitment – a worldview that catching cancer early is a prime overwhelming driving force, like the American Cancer Society has had in the past.  (I think the ACS has been much more nuanced and reasoned in their responses in the past few years as compared with the past.)  The AUA has announced that it is “outraged and believes that the Task Force is doing men a great disservice by disparaging what is now the only widely available test for prostate cancer, a potentially devastating disease.”  I think the AUA is wrong, and that the USPSTF’s recommendation is more balanced and reasoned than the AUA states.

Basically the USPSTF claims that there are reasons not to screen for prostate cancer using current techniques, especially the PSA test.  The summary:

The U.S. Preventive Services Task Force (USPSTF) concludes that the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 years. 
Grade: I Statement
.

The USPSTF recommends against screening for prostate cancer in men age 75 years or older.
Grade: D Recommendation
.

Paul Menzel and I have written about a number of factors which should be involved in recommendations and/or resource allocation associated with prevention screening, and I won’t repeat those items in this blog.  I will mention, however, that Diana Petitti’s chapter 5 of our book, Prevention vs. Treatment:  What’s the Right Balance? looks at some of those issues as well from a former USPSTF member’s insider view.

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Whose Bait and Switch? We all need fair play in health care.


When I was a resident my “mentors” did what most physicians do:  they taught me how to write-up preventive screening procedures as diagnostic or therapeutic ones so that they (and the patients) could get reimbursed by insurers.  So, a screening mammogram to detect early breast cancer, which wasn’t covered in the 1970s and 1980s in most insurance contracts, was written as “mass, rule-out cancer” or a screening resting EKG (which we now know is of little value) was recorded as “chest pain, rule-out ischemic heart disease.”

Surveys of physicians done by reputable researchers in the late 1980s and repeated in the late 1990s/early 2000s showed many physicians knowingly coded screening procedures fraudulently (see for example JAMA 1989;261(20):2980-85; JAMA 2000;283(14):1858-1865).  In the 1989 survey the researchers found that,

The majority [of physicians] indicated a willingness to misrepresent a screening test as a diagnostic test to secure an insurance payment…Most physicians indicated a willingness to engage in deception in some circumstances, justifying their decisions in terms of the consequences and placing a higher value on patient welfare and keeping confidences than on truth telling.

In the 2000 article, Wynia, et. al. concluded that:

A sizable minority of physicians report manipulating reimbursement rules so patients can receive care that physicians perceive is necessary.

Now the tables have turned.  The health reform act (known as the Accountable Care Act, or ObamaCare) has a provision that requires prevention procedures to be covered at 100% without a co-pay or deductible.

Secondary prevention is the use of screening procedures like colonoscopy to detect existing disease before it has signs or symptoms (see Prevention vs. Treatment:  What’s the Right Balance? pages 12-13 for more details). This preventive screening procedure means that something is being done without a suspicion of existing irregularity –  cholesterol is being checked to see if it is abnormal (not because it’s been abnormal and the patient wants to see if treatment has brought it down), or a colonoscopy is being done when there are no symptoms or signs that would suspect colon cancer (not because of an already established positive blood stool test, or presence of previous polyps, or prior diagnosis of colon cancer).

So physicians can get rid of their deceptive practices of old and request the procedure for what it is.  Let’s hear it for the system now encouraging moral integrity for physicians!  At least given old practices.

Covering new benefits, of course, costs more money for insurance plans, which will have to raise premiums to cover these new benefits.  If the actuaries for insurers haven’t already raised the premiums (or requested raises, which the state insurance commissioners may have nixed or reduced), then no pity on them – they had fair warning.  But presumably they have factored these newly covered benefits into their premiums, so now, as reported by the AP (see here), they are simply gaming the system the way physicians have for years.

In my experience in the health insurance industry in the 1980s and early 1990s we found many physicians gaming the system in many ways – up-coding procedures, mis-coding procedures, splitting (unbundling) what should have been bundled procedures, mis-dating follow-ups so they didn’t look as if they were for bundled payments, etc.  At the same time, reputable insurers tried to administer health insurance contracts quickly and fairly.  At Aetna, where I was medical director of the claims department, we prided ourselves on clearing claims very rapidly.  Where there were questions, we attempted to review and adjudicate the claim as soon as information was received to clarify the questions.  98-99% of all claims were paid without question.  But on a claims base of millions a day, 1-2% would still kick out >1500/ day.  Not all of these were medical issues, sometimes they were contractual benefits or eligibility ones which were handled by other departments.

Certainly we heard of irreputable insurers in the business, looking for ways not to pay claims.  But that wasn’t our culture.  I’ve been out of the health insurance business for 21 years, so things may have changed.  (OK, please don’t write in about your individual claim problem.  We’ve all had disappointments with one or more claims if we’ve lived long enough and submitted enough claims to health insurers.)

I’m not trying to be an apologist for insurers – I know they can be frustrating and difficult to deal with sometimes.  And certainly what they are doing now – changing the definition of a screening procedure to a diagnostic one because of findings from a screening procedure – seems deceitful.

My advice to individuals who experience this is to be sure that (a) your physician writes clearly that the requested procedure is for screening, (b) the screening requested is clearly within the guidelines of the US Preventive Services Task Force A or B recommendations, (c) you be vocal and proactive in talking with the insurer and provider in advance, and (d) if you get a billing surprise, appeal the decision as many times and layers as necessary.

So while the patient is asking for fair play from the insurer, at the same time the insurer is asking for fair play from the doctor and patient – don’t misrepresent the purpose of the test as screening if indeed it is diagnostic because of pre-existing symptoms or signs.  In that case the bait and switch isn’t the insurer’s fault, but the patient’s and doctor’s.  We all need fair play – honesty, not manipulation – in health care.

PSA Screening and Prostate Cancer


Making health policy involves many different aspects of life:  scientific evidence of a highly predictive diagnostic test, reasonable price, competing resource demands, comfort and convenience of a test, seriousness of the disease being detected, impact of the disease on the individual and the population, etc.

Anyone who’s been involved in health policy debates will recognize that, except for predictive value of the test and actual cost of the test, both of which can be determined somewhat objectively, all of the rest of the items listed above are laden with values (and one can argue even arriving at the predictive value involved significant calls on various values in doing the studies).   Evidence-based medicine only provides information, it doesn’t provide a support of values and how they will be applied in society.

Rather than reproduce some of the less-than-obvious arguments about screening for prostate cancer here, those interested can find more information in Paul Menzel’s and my recent posting on the Oxford University Press blog website.

Wealth and Conflicts of Interest


Carl Bialik’s column in the Wall Street Journal this past weekend (Nov. 12, 2011) discusses the “Income Ladder’s Sticky Steps.”  He tackles the difficult question of assessing mobility, showing how defining the strata may change the conclusions that can be reached, including issues such as (1) What age groups should be included? (2) How do you handle natural progress of careers; older employed folks usually make more than they did when they were younger because their careers progress? (3) Would we be better tracking longterm earnings, as there can be natural fluctuations from year-to-year?

These have important implications when trying to look at economic progress.  For example, the Occupy Wall Street folks claim they are the 99% who are below the chasm of the 1% highest earners.  Of course they are – the 99 out of 100 people will be in the 99% by definition.  Except for celebrity guests of the Occupiers (who likely are in the 1%), those with the time on their hands to protest will be in the 99%.

Bialik states, without making further comments, “And none of the income measures explicitly includes wealth, which is distributed more unequally than income.”  This is an important statement.  Bialik is not the only one who recognizes but does not deal with the issue of wealth.  In Conflicts of Interest in medicine and health care wealth is at least partially ignored.  How?

Most conflict of interest disclosure requirements for authors in journals or speakers in continuing medical education events include provisions to disclose relationships with companies or other interests.

The International Committee of Medical Journal Editors states:  “Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties).”

The American Council on Continuing Medical Education (ACCME) states:

2.1 The provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. The ACCME defines “‟relevant‟ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

In the ACCME’s case financial relationships are defined as “…those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit.”

How does this normally exhibit itself in CME speaking activities?  In my experience the moderator of a session will state “so-and-so discloses that (s)he owns stock in [Drug] Company” or “so-and-so discloses that she has been paid an honorarium by [Device] Company” and it is left at that.  As we know, disclosure doesn’t fix the conflict, it merely reveals it.   Loewenstein notes related to the physician-patient relationship,

Disclosure may give the adviser a “moral license” for strategic exaggeration in the adviser’s best interest. (“I told her I had a conflict—now, I can recommend the surgery.”) Having disclosed a conflict of interest, moreover, advisors may feel compelled to give advice in an extra-forceful fashion.

This may be similar for the speaker-audience relationship, “I [the speaker] have disclosed my conflict, now I needn’t worry about it, or I may feel free to discuss it even more than if it were hidden.”

However, the key question that needs disclosure is “What does this relationship mean to the speaker and how has it influenced his/her presentation of information?”  Simply knowing that someone has been paid an honorarium or owns stock in an enterprise doesn’t tell the audience if such ownership is meaningful.  More importantly, what does that represent in terms of one’s income or wealth?  If the speaker has net worth of $100 million, owning $10,000 of stock likely is relatively meaningless.  On the other hand, if the speaker’s net worth is only $200,000, that $10,000 of stock may be critical for how she wants to please either the commercial interest (to get more stock or honoraria) or the audience (to purchase more of the product offered by the commercial interest).

(As an aside, at a recent Harvard University Program in Ethics and Health conference conditional cash transfer payments to encourage health promoting activities in second world countries was discussed.  As I recall, levels of payments had to approach 20-30% of annual income to get behaviors to change substantially.  This, of course, differs from findings related to physician behavior, which is influenced by small pharmaceutical company gestures.)

So, while ignoring wealth as the denominator of disclosure is usually done, we should consider the issue as a much more important measure.  Further there likely is some interactive relationship between meaningful financial ownership (wealth) and income.  Income fluctuations may have little meaning if the amounts are small, or if one has equilibrium with a lifestyle that is fully supported by drawdowns on existing wealth (not requiring additional annual wealth through income or increases in, for example, stock value).

Because of the complexity of the interaction of wealth, income, and meaningful bias/influence the leading medically-related institutions are moving to requiring disclosure of any financial relationship between an author/speaker/influencer and a commercial interest.  This makes sense, in that research indicates that we often don’t let data get in the way of our biases, which can easily come from financial self-interest, and that even small conflicts can result in unconscious bias.   Until we have more reliable data on the relationship between wealth and income this is probably prudent, but also recognizably excessive.

How to find the right balance?  More easily done when more research is completed.

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