Sebelius Is Wrong - The USPSTF Is Setting Policy

Posted on November 19, 2009
Filed Under General Rationing Issues, Healthcare Reform |

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There is no doubt that the surprising new recommendations on breast cancer screening, published this week by the United States Preventive Services Task Force (USPSTF), has created a firestorm.

As well it should. DrRich has already documented how these new recommendations represent the first clear manifestation of what some have called “death panels.” (And, rather than simply asserting the USPSTF has become a death panel - as so many of his colleagues from the low-brow right wing have done - DrRich has performed the very great public service of actually defining the specific characteristics of a “death panel,” then showing how the USPSTF’s bastardization of the clinical evidence for the purpose of cost savings so nicely fits that definition. You’re quite welcome.)

Hinted at, but unspoken, in DrRich’s earlier analysis of the USPSTF’s new recommendations, is the idea that the panel’s action in this regard is not merely a one-time event, but is likely establishing a pattern for future behavior. After all, this is the second set of controversial recommendations the USPSTF has released in recent weeks - the first being a broadside against various newer methods of screening for coronary artery disease.

DrRich, of course, has been long anticipating the onset of a war on preventive medicine. As he has pointed out, preventive medicine is very expensive, and greatly increases the overall cost of healthcare (at least over the short-term, which is all our healthcare system can afford to worry about). Under any covert rationing regime, preventive medicine will have to be suppressed. So it’s only a matter of time until preventive care is subverted, whether that subversion is conducted subtly or blatantly.

Is that what we’re beginning to see here? Is the surprising new activism of the USPSTF - until now a quaint, warm-and-fuzzy, advisory-only outfit - the first shot across the bow?

It was the remarkable statement released yesterday by Kathleen Sebelius, the Secretary of the Department of Health and Human Services (the agency which appoints the membership of the USPSTF), that prodded DrRich to get off his duff to find out.

Sebelius said:

“There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S. Preventive Task Force is an outside independent panel of doctors and scientists who make recommendations. They do not set federal policy and they don’t determine what services are covered by the federal government. . . The Task Force has presented some new evidence for consideration but our policies remain unchanged. Indeed, I would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action. . .Keep doing what you have been doing for years — talk to your doctor about your individual history, ask questions, and make the decision that is right for you.”

This statement is so reasonable and reassuring and straightforward (independent panel, makes recommendations only and not policy, no change in coverage, keep doing what you’re doing) that it made DrRich very suspicious. For, during our painful national ordeal of birthing healthcare reform, DrRich has learned that when our political leaders make very definitive, very clear public statements regarding our healthcare, they are usually missing the truth by about 180 degrees.

Thinking he might find clues about what’s really going on by perusing the healthcare reform bill, DrRich reluctantly dove into HR 3962 - the bill lovingly nurtured by Nancy Pelosi, and recently passed by the House of Representatives. DrRich wanted to discover what role, if any, the USPSTF might be playing under our new healthcare system. The search was not easy and it was not pleasant, for HR 3962 is not meant for actual interpretation or enlightenment, but rather, for obfuscation. But he found what he was looking for.

DrRich will attempt to present his findings as a neat progression, but assures his readers there was nothing neat about it (as you can tell by noting the various sections one must find in order to assemble the whole story).

Simply, under HR 3962:

1) The USPSTF will be renamed as the “Task Force on Clinical Preventive Services” - TFCPS (Section 3171, pages 1318-1319)

2) The TFCPS shall “review the scientific evidence related to the benefits, effectiveness, appropriateness, AND COSTS (emphasis DrRich’s) of clinical preventive services” and determine whether those preventive services ” meet the Task Force’s standards for a grade of A or B.” (Section 3131, page 1292).

3) If the TFCPS determines that a preventive service has achieved a grade of A or B, “the Secretary shall ensure that the [service] is included in the essential benefits package under section 222.” (Section 3143, page 1307).

4) The “essential benefits package” will cover “preventive services, including those services recommended with a grade of A or B by the Task Force on Clinical Preventive Services recommended for use by the Director of the Centers for Disease Control and Prevention.” (Section 222,  page 106).

And finally, the kicker:

5) “All recommendations of the Preventive Services Task Force and the Task Force on Community Preventive Services, as in existence on the day before the date of the enactment of this Act, shall be considered to be recommendations of the Task Force on Clinical Preventive Services and the Task Force on Community Preventive Services, respectively, established under sections 3131 and 3132 of the Public Health Service Act, as added by subsection (a).” (Section 3171, page 1319).

So, to summarize: The USPSTF, to be renamed the TFCPS, will review the clinical science AND THE COSTS of preventive medical services and give them a grade based on those findings. The grade will determine whether a preventive service is covered or not. Services that receive a grade of A or B will be covered, otherwise, not. Most strikingly, the current activities of the USPSTF - including its new recommendations on breast cancer screening and coronary artery screening - will become official healthcare policy, and will directly determine coverage, as soon as the new healthcare reform plan is passed.

In fact, even before we actually have  healthcare reform, the plan has been implemented. This week, we are seeing it in action. The “recommendations” of the USPSTF on breast cancer screening - protestations of Ms. Sebelius to the contrary notwithstanding - are indeed intended to be dispositive.

It’s all there, in plain governmental legalese.

Until today, DrRich did not understand the real significance of the “grades” assigned to preventive services by the USPSTF, and so he did not report those grades in his previous post. He apologizes. He will correct that oversight right now:

Breast cancer screening for women aged 50 - 74 received a grade of B. These services will be covered.

Breast cancer screening for women aged 40 - 49 received a grade of C. These services will not be covered.

Breast cancer screening for women aged 75 and older received a grade of I (meaning there is insufficient data to say one way or the other). These services will not be covered.

And that, dear readers, is the real upshot of the new breast cancer screening recommendations.

Releasing these recommendations at this particular time was clearly a mistake, and is another obvious sign of governmental incompetence. Why would the feds want to give us a peek behind the curtain at this critical moment, when final passage of healthcare reform is in the balance? One can readily understand why Ms. Sebelius’ corrective action - her soothing but blatantly misleading statement - was necessary.

Ms. Sebelius’ own culpability in issuing this grossly erroneous statement can be interpreted in three ways. Perhaps she’s just lying. Perhaps she’s ignorant of the role her own panel has already begun playing in determining which medical services are to be covered and not covered. Or, perhaps she’s displaying a Clintonian facility with the English language (here, as it happens, employing a variation on the classic “depends on what the meaning of is, is”), and accordingly she’s reporting the currently truthful statement that the USPSTF’s “recommendations” have no effect on present policy, while simply neglecting to mention that those selfsame “recommendations” are indeed going to become policy very soon, the moment healthcare reform is passed.

For practical purposes, perhaps it matters little whether we are being led by the ignorant, by liars, or by people who are cleverly deceptive. Whichever is true, we are in a bad state, and the results of such leadership will affect us profoundly in many ways.

But whatever the balance between ignorance and deceptiveness among our leaders, it should be clear to all that the war on preventive medicine - long predicted by your sad correspondent, DrRich, as a necessary component of covert rationing - has officially begun.

Comments

15 Responses to “Sebelius Is Wrong - The USPSTF Is Setting Policy”

  1. Peter on November 19th, 2009 12:49 pm

    This is quite frankly shocking, but in retrospect, all expected based on previous rhetoric about cost-containment.

  2. paulie on November 19th, 2009 10:52 pm

    Dr Rich - for some reason that now escapes me, I thought better of you. This post (along with your recent “death panel” post on the same topic) sounds like it was ghostwritten by Rush Limbaugh. You both have the gift of making paranoia sound reasonable, if only momentarily.

    Assume, if you will, that someone’s fairy godmother waves a magic wand and that an explicit, publicly accessible and commentable review process, backed by applicable clinical research when available, suddenly becomes the governing principle behind health care coverage decisions. (Because that’s the only way it’s gonna happen.) Wouldn’t an ideal body to initiate policy making under such a system look a lot like the USPSTF? Isn’t this sort of process (as someone who says he favors overt over covert rationing) actually what you say you want? Or maybe the recommendations, which in reality represent a fairly minor shift from previous recommendations by the same group, aren’t PC enough for you? Maybe you would rather have a panel made up of pink ribbon-wearing family members of breast cancer survivors? (I admit that you probably wouldn’t miss nearly as many cancers with a program of monthly mammograms and yearly random breast biopsies starting at age 20.) Or how about a panel of breast surgeons and mammographers, who derive their income and professional satisfaction from the screening program as it exists now? (That’s basically who drives the American Cancer Society guidelines. To a man with a hammer…) Or Democratic Congresspersons?

    And if some empowered body, expert or not, decides the previous recommendations for breast cancer screening starting at age 40 should be covered, how about prostate cancer? Even though some people incontrovertibly continue to die miserable deaths from that disease, and some people are saved by treatment from such deaths, we are both well aware that recent studies indicate an even more tenuous net mortality benefit from screening for prostate cancer than for breast cancer. Would a cutback in coverage for prostate cancer screening constitute prima facie evidence that the group who recommended against it was a “death panel”? And if prostate cancer screening is covered, how about lung cancer, for which screening with chest CT makes sense to some people, but hasn’t yet been shown to actually provide any net benefit at all? Let me remind you that some radiologists are estimating in print that 2% of cancer in the USA might be caused by radiation from CT scanning…

    The truth is that the bar for any cancer screening test OUGHT to be set high. By definition, we are talking about asymptomatic individuals, who have lots other things to occupy their time and resources. By the time one accounts for lead time bias, intercurrent death from other causes, and the increasingly clear fact that some cancers discovered by screening never would have caused any trouble anyway, one is left with a large benefit for a tiny minority of individuals, which incurs a significant burden of radiation, surgery, chemotherapy, emotional trauma, and (yes)cost to be borne in varying proportion by the vast majority of individuals who derive none of the benefit. The sad truth is that this is the state of the art. The debate from the societal standpoint should revolve around the question of how much juice for the minority is worth how much squeeze on the majority - and the equation is different for each different disease. (By the way, are you personally going to get screened for prostate cancer? Not me.) As your posts demonstrate, that’s not what it’s come to be about. The populist genius of Sarah Palin is effectively demonstrated by how much the simple phrase “death panels” has done to divert attention from the real issues - and shame on you for participating in that diversion.

  3. Chris FOM on November 19th, 2009 11:11 pm

    Paulie, I think you and DrRich are not so far along. Reading DrRich’s two posts on this matter, it would seem that his objection to the changes are not that the changes are necessarily bad, but rather that they are being made for the wrong reasons.

    In a system of open rationing, medical care is withheld from those who could benefit from it, and they know that it is being withheld. That is the key difference here. The USPSTF is trying to say that the evidence no longer favors these treatments, when in reality the data behind that decision is suspect.

    As one of my attendings has drilled into my head, the first rule of evidence based medicine is do the patients in the study look like my patients? Given that the way that abnormal mammograms or breast exams are handled in the US differs substantially from the way they are handled in other countries, evidence from studies done in those other countries cannot be extrapolated to apply to an American patient population.

    DrRich therefore feels that what is really happening here is that data is being misapplied to give the impression that there is evidence against routine screenings when the real reason to eliminate those screenings is one of cost. This therefore falls directly under his vision of covert rationing: the USPSTF is actually performing a cost-control measure (it takes screening nearly 2000 women under 50 to extend one life, vs. just over 1300 for women between 50 and 60) while claiming that they’re merely following where the evidence leads them. I’m not entirely convinced (frequently we use equally poor data to favor more test and procedures), but a case could be made.

    The decision in this case may well be the right one. The evidence behind mammograms (and prostate screening for that matter) is not nearly as clear-cut as colonoscopies, and they may well not be helping much. Even if they do help, the cost may well be more than it’s worth. But the decision isn’t what’s being discussed here. You can do the right thing for all the wrong reasons and still make a bad decision because if the rationale is bad next time you might do the wrong thing instead.

    Basically, I think that if the USPSTF came out and directly stated that screening mammograms for women under 50 just aren’t worth the cost, DrRich would have no problems. That’s open rationing. But when they hide cost-cutting and try to dress it up as evidence based medicine instead, it’s covert rationing.

  4. Liz on November 19th, 2009 11:45 pm

    DrRich, great investigative work! I am impressed that you found the connection within that 2000-page document.

  5. Hal Dall, MD on November 20th, 2009 1:34 am

    Thank you for an excellent pair of posts, DrRich!

    Paulie, I couldn’t tell whether you thought prostate screening would be covered under HR 3962. It’s USPSTF grade D…not covered, but under the older criteria of medical ineffectiveness rather than budgetary ineffectiveness with a fig leaf camo of EBM.

  6. MacGhil on November 20th, 2009 9:23 am

    They’re at it again!

    Guidelines Push Back Age, Frequency for Cervical Cancer Tests
    http://www.nytimes.com/2009/11/20/health/20pap.html?_r=1&emc=na

  7. james gaulte on November 20th, 2009 10:09 am

    My question is-from your reading of the bill,to what groups will the “essential benefits package”apply. Besides Medicare and Medicaid,which I assume to be included, will the public option policies be similarly governed ?

    Your investigative work needs to be widely circulated.

  8. DrRich on November 20th, 2009 11:17 am

    Dr. Gaulte,

    I can’t really figure it out. The essential benefits package is what is required in any “qualified” health plan. Through the proposed exchange, you can buy a qualified plan at three levels - basic, enhanced, or premium - but all levels all appear, by law, to have offer the same benefits, and the only thing that changes is the level of co-pay. The bill appears to provide for a “premium-plus” plan that offers additional benefits, but as nearly as I can tell the only additional benefits that are allowable have to do with dental and eye care.

    The part of the bill that talks about health plans, benefits, and exchanges, however, are particularly difficult for me to understand, so my level of confidence I’ve got it right is pretty low.

    If you believe (as I do) that the ultimate goal is a single-payer system, however, then the details are unimportant - whatever is covered in an “essential benefits package” is covered, what is not is not.

    Rich

  9. Michael Kennedy on November 20th, 2009 1:14 pm

    Good work and I have linked to it once again. I was not at all surprised at the pap smear story as ACOG knows how to be “relevant” in the new age of government care. I did note that one of the guidelines says “Clinical breast exam” is not covered. That is not self exam but doctor exam. I suppose the philosophy is what you don’t know can’t hurt you. I still have my sister 28 years after I advised her to have subcutaneous mastectomies for extensive DCIS on biopsy. She had invasive cancer in the specimen. Even her surgeon thought I was giving bad advice. I spent 40 years as an aggressive surgeon and still regard Mark Twain’s advice as valid.

    ““Twenty years from now you will be more disappointed by the things that you didn’t do than by the ones you did do.”

    The solution for health care costs is to go back to paying for routine care, including mammograms, ourselves and reserve insurance for the unexpected events. When I began medical school, that was the case. What we have now is a culture that insists on controlling all behavior and we can’t afford it in health care.

    The definition of rationing, by the way, requires control by an outside agency, not price. Look it up.

  10. Frank on November 20th, 2009 3:23 pm

    DrRich has been exposed. The best evidence shows no clear benefit for screening and significant harm. Why would the USPSTF recommend screening? Nice job Rich, bringing death panels and your blatant anti-government biases into the discussion. One less blog to read.

  11. Hal Dall, MD on November 20th, 2009 4:59 pm

    Hot off the press from the Senate bill:

    SEC. 2713. COVERAGE OF PREVENTIVE HEALTH SERVICES.
    (a) IN GENERAL.—A group health plan and a health
    insurance issuer offering group or individual health insurance coverage shall provide coverage for and shall not impose any cost sharing requirements for—
    (1) evidence-based items or services that have
    in effect a rating of ‘A’ or ‘B’ in the current
    recommendations of the United States Preventive Services Task Force;

  12. The Contrarian on November 21st, 2009 11:14 am

    Welcome to the tragedy of the commons. All this discussion is irrelevant if services such as mammography are paid for by individual resources. The total cost of screening per woman screened is likely on the order of a few thousand dollars over the course of a decade, an represents pennies per day. This is hardly the stuff that insurance shoudl pay for, being neither unpredictable or extremely costly.

    The question is whether the present data on the effectiveness of mammography when presented to an informed consumer would convince individual women to spend their own money.

    Once you move to a system where resources are placed in a common pool and are allocated via some sort of consensus driven process, you have a mess. This latest controversy clearly shows that any attempt to base decisions on a scientific consensus are doomed. It involves people and the decision will be a political one. End of story. Now all we need to do is extrapolate this out to the entirety of health care decisions regarding allocation.

  13. Michael Kirsch, M.D. on November 22nd, 2009 10:24 am

    Sebelius is now in the ‘Mother of All Retreats’, escaping from the prudent recommendations of her own agency’s task force. Hope for comparative effectiveness research is dissolving. We learned a lot last week, and the lessons make me more pessimistic that real reform will emerge. See http://bit.ly/656CwP

  14. Ken on December 21st, 2009 5:48 pm

    Interesting that it took a woman (I’m assuming) to make the following comment, and a bunch of men (apparently) to ignore it: “I admit that you probably wouldn’t miss nearly as many cancers with a program of monthly mammograms and yearly random breast biopsies starting at age 20.” - paulie on November 19th, 2009 10:52 pm.

    The “oost” in the cost-benefit analysis of screening or any other form of preventive medicine has to take more than dollars into account. Ultimately, it’s a judgement call, but frankly I would trust the USPSTF to do a better job of making that call than the ACS or any other organization that is likely to have ties to special interests.

    Also, the USPSTF assigned routine screening mammography among women in their 40’s a grade of “C”, meaning “[t]he decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms.” It is clearly misleading to translate this as “The USPSTF has increased the age at which women should begin having screening mammograms from 40 to 50″ (DrRich, “Breast Cancer Screening and ‘Soft’ Death Panels”, posted 11/17/09).

  15. DrRich on December 21st, 2009 7:21 pm

    Ken,

    1) Since any preventive service graded by USPSTF as “C” or below will no longer be covered by “qualified” insurance plans once healthcare reform legislation becomes law, the USPSTF has, in effect, moved routine mammography under age 50 from a covered service to an uncovered service - no matter how benignly they describe a grade “C.” So I do not believe I am being misleading. I could even argue that, given what a grade “C” actually means in terms of insurance coverage, telling us to rely on the benign-sounding descriptor for grade “C” is what’s misleading.
    2) I am not arguing that mammograms are great in 40 year old women, and that therefore it’s a travesty to withhold them. I am merely asking a simple question: “By what reasoning did the USPSTF deem mammography to be a useful service for 50 year old women, but not for 40 year old women?” And in exploring their published document to find clues as to their rationale, I have found their reasoning to be opaque, and (since it sets a precedent), disturbing.

    Since the USPSTF will be officially establishing coverage policy for qualified health insurance plans, I believe their reasoning should be clear and explicit. It is not.

    Rich

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