Can Sebelius actually NOT cover the costs of PSA testing for Medicare patients?


A key concern associated with the USPSTF recommendation that widespread “screening” of uninformed men be eliminated is that this recommendation would lead to non-coverage of PSA testing in otherwise healthy men.

In fact, based on a careful reading of the Patient Protection and Affordable Care Act (PPACA) and the Social Security Act, it would seem very likely that the Secretary for Health and Human Services must, in fact, cover the costs of annual PSA testing for Medicare patients who are 50 years of age or older.

According to the Patient Protection and Affordable Care Act, Section 4105(a),

… the Secretary may —

(1) modify —

(A) the coverage of any preventive service described in subparagraph (A) of section 1861(ddd)(3) to the extent that such modification is consistent with the recommendations of the United States Preventive Services Task Force

However, according to Section 4105(b) of PPACA,

Nothing in the amendment made by paragraph (1) shall be construed to affect the coverage of diagnostic or treatment services under title XVIII of the Social Security Act.

When we look at the Social Security Act, we discover that, in Sec. 1833 of the Act, see subsection 1833(h)(1)(A)

... the Secretary shall establish fee schedules for clinical diagnostic laboratory tests (including prostate cancer screening tests under section 1861(oo) consisting of prostate-specific antigen blood tests) …

and that in Sec. 1861(oo)(1) of the Act prostate cancer screening is very specifically defined as a diagnostic test, as follows:

The term “prostate cancer screening test” means a test that consists of any (or all) of the procedures described in paragraph (2) provided for the purpose of early detection of prostate cancer to a man over 50 years of age who has not had such a test during the preceding year.

Sec. 1861(oo) of the Act goes on to state explicitly that a PSA screening test includes both a “digital rectal examination” and a “prostate-specific antigen blood test”. This seems to be about as legally clear as one can get.

Sec. 1861(oo)(2)(C) of the Act also states that, after 2002, a PSA screening test should also include

… such other procedures as the Secretary finds appropriate for the purpose of early detection of prostate cancer, taking into account changes in technology and standards of medical practice, availability, effectiveness, costs, and such other factors as the Secretary considers appropriate.

There is no mention of the possibility of eliminating the PSA test.

If this interpretation of the law is correct (and we have not consulted a specialist in social security or health law), where does it leave us?

It would appear that:

  • For men of 50 years and older, coverage of the costs of an annual PSA test is legally enshrined in current law if they are Medicare patients.
  • The law appears to further enshrine the idea that any man of 50 years or older is reasonably entitled to consider that an annual PSA test along with a DRE is a reasonable and standard form of test, and that costs should therefore be covered by any insurance provider (Medicaid included).
  • The law does not include coverage of PSA testing for men under 50 years of age.
  • The law does not include coverage of a baseline PSA test for men under 50 years of age.

Should it prove true that the Social Security Law and the Patient Protection and Affordable Care Act have indeed ensured that men on Medicare are entitled to a PSA test each year after reaching their 50th birthday, then it seems highly likely that commercial insurers will also follow this interpretation. State Medicaid beneficiaries may find a less receptive audience, given the financial constraints on most State Medicaid budgets today.

Sadly, it will be men under 50 who may suffer most and yet be most at risk if they are not diagnosed early through the combination of a baseline PSA test and close monitoring — as appropriate — if that first PSA test shows a level of > 0.7 ng/ml. It would seem like a complete travesty for us to be giving annual PSA tests to men in their 70s who are highly unlikely to benefit from early detection, and yet not to be able to give the same test to men of 40 to 45 years of age who potentially have the most to lose from a delay in diagnosis of potentially or actually clinically significant.

The “New” Prostate Cancer InfoLink continues to hold to its previously stated position that the proposed new draft recommendation issued by the USPSTF is reasonable, but that the costs of covering this test should be included in the costs of an annual physical for all men > 35 years of age if the patient and his doctor believe such a test is warranted for any reason.

38 Responses

  1. And what happens to the screened men between 35 and 50 diagnosed with indolent and low-risk prostate cancer that are treated as if they have aggressive disease, and then have 25 to 50 years (more than half their lives in many cases) to live with both the inevitable and potential damage caused by today’s conventional forms of treatment?

    Though I’m pleased to see all the newly-minted converts to the appropriateness of active surveillance since the USPSTF draft recommendations were released — suddenly AS has become this hugely popular and viable option to justify and ameliorate the risk of over-treatment — men < 50 aren't included in any active surveillance protocol I've ever run across.

    Perhaps USPSTF, charged with supporting preventive and primary care professionals in treating the whole person (including protecting their patients from unnecessary maiming caused by over-treatment), consciously or unconsciously has made this seemingly radical recommendation to stake out what they knew the prostate cancer treatment and advocacy communities would view as an extreme position to shed some heat and light on the very real problem of over-treatment and to initiate a conversation in the larger community about the awful costs to patients’ quality of life, as well as the cost of unneeded care to our health care system.

    Many without a vested interest in defining and diagnosing prostate cancer as broadly as possible found the AUA’s recent PSA recommendation to be more about opening new markets for their services by diagnosing younger and younger men, even as the evidence piles up that much of the treatment of older (and arguably all) men is gratuitous and damaging, than to be about identifying and “saving” the lives of younger men with aggressive prostate cancer, who still constitute a quite low percentage of all younger men diagnosed with the disease.

    And for all the platitudes about the need for better diagnostic tools that distinguish low-risk and high-risk prostate cancers, a skim through the research summaries and open trials at the NIH, ACS, and PCF doesn’t suggest a meaningful focus on the very issue required to solve the over-treatment problem. Further, the interest in focal therapy development in the US, with a few happy notable exceptions, seems to border on something closer to antipathy than a healthy intellectual skepticism.

    Folks outside the prostate cancer communities look at odds for low-risk vs. high-risk disease across age cohorts, look at the odds for complications that are maiming and life-altering across age cohorts, look at the entrenched commitment to the conventional therapies that cause such damage, and the entrenched culture that rationalizes such damage… And primary care providers, patients, and their partners reasonably ask this question: What can we responsibly do to avoid engaging with prostate cancer culture in the first place? And based on the evidence, one reasonable answer is to not screen men without risk factors in the first place. I hope once the knees stop jerking, that one positive outcome of the USPSTF recommendations will be a much, much broader dialogue about all the consequences of conventional prostate cancer protocols and treatments.

  2. Tracy … As far as I am concerned, a 35-year-old with Gleason 6 disease and a PSA of 2.7 ng/ml can go onto active surveillance to defer the need for treatment until it is evident. … However, I do want to find the guys like Tony Crispino and David Emerson who are diagnosed with aggressive, clinically significant disease in their 40s so that we can try to cure them!

    :O)

  3. “As far as I am concerned, a 35-year-old with Gleason 6 disease and a PSA of 2.7 ng/ml can go onto active surveillance to defer the need for treatment until it is evident. …”

    Well, then AUA needs to come out with a strong, unequivocal recommendation in support of AS for men < 50 and work like dogs to ensure it's implemented in urology practices across the country. I'm not seeing it. …

  4. Neither am I … but to be fair there are no data to support such a management strategy in younger men at this time. At present this is a matter for discussion between a physician and his patients.

  5. Actually, I don’t consider that to be a fair argument at all. It’s not just that there’s a lack of “data”. There is a lack of a meaningful body of research on AS as a strategy for managing prostate cancer in men under 60 and certainly under 50.

    In the prostate cancer treatment community there remains an a priori, untested, unproven assumption that younger men require immediate, radical treatment. Now, I’m not assuming conspiracy here in the research community. I suspect the assumption of need for immediate radical treatment and the subsequent lack of research, and more importantly, lack of interest in research in over-treatment of younger men, is a remnant of the pre-PSA testing era combined with the reality that the large majority men with diagnosable prostate cancer continue to be over 60.

    There may be no malicious intent here, but it’s still fallacious reasoning to assume that because men < 60 are more likely to present with symptomatic and/or higher-risk prostate cancer that all men < 60 with prostate cancer should be treated as if it’s higher-risk prostate cancer. The universe of men with the for potential prostate cancer has simply been inaccurately defined, to the grave expense of younger men with low-risk prostate cancer. Now, as I write this, I realize I'm boxing myself into an intellectual corner where the answer is population-based screening of younger men.

    However, the concern appears tepid, at best, by the prostate cancer treatment and advocacy community to the indisputable realities of over-treatment in men of all ages. When this tepid concern is combined with the cavalier disregard for rendering hundreds of thousands of men impotent every year — at least half of them permanently — who did not medically require that outcome, the treatment community deserves scrutiny, critique, and a demand for accountability from the broader health care community, from the general population, and from insurance providers, both public and private.

    I understand that you've been put in position to make an argument seriously lacking in both moral and clinical authority, so the following criticism is not personal, but don't you think it's a tad disingenuous to argue that because no research exists — because the prostate cancer treatment community refuses to even ask the question — to support AS as a treatment protocol in younger men that a “physician and his patients” should have to work it out amongst themselves?

    We all know that's an untenable recommendation fraught with disincentives that have nothing to do with the appropriateness of treatment recommendations for younger men diagnosed with low-risk prostate cancer. Without an explicit AUA or other credible governing bodies' recommendation for AS as a protocol to manage low-risk prostate cancer in young men, the malpractice liability issue in and of itself argues forcefully to providers against your recommendation for an informal, off-protocol approach. Individual physicians willing to put their patients' needs above their own legal risks are stuck with advocating for AS in a circumscribed fashion due to the lack of research and uniform protocols in support of AS. And for the thousands of community-based prostate cancer treatment providers who perceive an economic gain in promoting radical therapy as first line treatment, there's zero incentive to acknowledge the realities of over-treatment in younger men.

    I am grateful to the USPSTF for bringing attention to the realities of prostate cancer over-treatment into the arena of public discussion. But couching the discussion in the issue of PSA-screening is vexed because there are certainly legitimate arguments and obvious cases where PSA screening of men without risk factors was effective in prolonging their lives. Be clear, we all want the Tony Crispinos and David Emersons of the world around.

    The sad realities remain, however. Most men diagnosed and treated for prostate cancer are over-treated for prostate cancer. About half of both appropriately treated and over-treated men suffer a measurable and permanent diminution in quality of life as a result of current treatment standards. Improvements in current treatment technologies to date have not succeeded in decreasing risks for measurable and permanent diminution in quality of life. The majority of ongoing research in the prostate cancer field is neither focused on improving capacity to distinguish between low-risk and high-risk cancers, nor in innovation in treatment technologies that decrease risks for measurable and permanent diminution in quality of life.

    As that old sharpie, Mr. Einstein so eloquently said, the definition of insanity is doing the same thing over and over, but expecting a different result. Just like a dysfunctional family can benefit from the intervention of a caring therapist who can bring a broader perspective to understanding the dynamics of relationships, personalities, and interests and solving conflicts, perhaps it is time for intensive external review and intervention into the insular, self-replicating interests and priorities of the prostate cancer community. Because based on its defensive, self-justifying reaction to the USPSTF trial recommendations, the community appears to have no interest, or maybe even awareness, of the need to quit doing the same thing over and over and try something else.

  6. Mike:

    Thanks for the research into the health care/medicare/whatever issue with coverage for PSA testing. I could never find this info myself.

  7. Tracy:

    I hear a healthy dose of cynicism in your comments. To assume that the AUA is devoted to economic rather than medical interests is counter to what they say (e.g., this media release).

    Take a close look at the AUA literature (e.g., this media release) and you will find plenty of recommendations for active surveillance for the right candidates. Peter Carroll has been very proactive with his committee recommendations and reports for AS in men with low-risk, indolent disease.

    We can all agree that compliance may be another discussion!

    rd

  8. “The identification of high-risk cancers in younger patients is the most important goal of widespread screening efforts; however, these men are also at risk for the early detection and treatment of indolent cancers. Given young men’s high pretreatment functional levels in multiple health-related quality of life (HRQOL) domains, they may experience greater absolute functional declines than men who are older with poorer baseline function (ie, those who have the most to lose, lose the most).” (See Dall’Era MD et al., 2008.)

    Some folks in the prostate cancer community do understand and will acknowledge the costs of over-treatment. What will it take to energize the community to own this very serious problem?

  9. Tracy:

    This is a circular argument.

    There is no aggressive research policy re AS in younger men. This is true. Even if there was, it would take at least 5 years to get the beginnings of meaningful data. The AUA is going to want data, and so is AHRQ.

    Should we start such research? Absolutely. Tell Gerry Andriole to get a move on. This is right in his area of academic expertise!

    In the meantime I think it is perfectly reasonable for the individual physician and his/her patients to discuss and consider such a strategy. There are most certainly already some physicians out there doing this. Klotz’s series does include men under 50.

  10. Of course it’s a circular argument! But claiming it’s inappropriate to recommend AS because there’s no “data” to support it infers AS has been tested as a strategy for managing low-risk prostate cancer in young men and has failed. When you and I both know that’s simply not the case. How can an answer be wrong to a question few are brave enough to ask? And how many men have to preemptively and/or unnecessarily have their lives meaningfully damaged while we wait around for the prostate cancer treatment and advocacy community to feel confident that they can maintain research and clinical support for men with high-risk cancer, even while admitting that they’ve erred for a couple of decades in over-treating most of the men they’ve diagnosed and treated?

  11. Hang on … Who is saying that it is “inappropriate” to discuss active surveillance with young men with low- and very low-risk prostate cancer?

    As far as I am aware, all that anyone is saying is that there are few data … Because there are few data, I would argue that it is inappropriate to recommend active surveillance to young men, but that doesn’t mean it is inappropriate to discuss it as one of several possible options. There are no good data to support any form of invasive therapy in young men with low- and very low-risk prostate cancer either! All an honest clinician can offer is a series of options … all of which need to be carefully discussed.

  12. Gents:

    I don’t see a problem recommending AS in younger men, even without empirical data — for example, a guy with 1/12 cores, < 2 mm, 3 + 3. The proviso must be that the patient is VERY vigilant — i.e. frequent PSA tests, say every 6 months; biopsies every 18 months; diet and exercise; etc., etc.

    I accept we do not have the empirical back-up, but that is not a good enough reason not to recommend AS given the co-morbidities of Tx and their greater significance for younger men. We do know the dangers of cancer in younger men and the difficulty identifying whether it is indolent or aggressive … even when it exhibits low Gleasons.

    Young men cannot have it both ways — either they submit to interventionary treatment with its inherent risks or they comply with an AS protocol that will preserve all functions with only the minor risk of frequent biopsies.

    rd

  13. The AUA’s Clinical Guidelines for Prostate Cancer 2007 state:

    “Which patients are suitable candidates for active surveillance? Patients with lower risk tumors (low Gleason score, PSA level, and clinical stage) could be candidates for this treatment strategy.
    Several studies have shown that patients with lower grade, localized prostate cancer have a low risk for clinical progression within the first 10 to 15 years after the diagnosis.Thus, this treatment strategy may be best suited for men with a shorter life expectancy. Generally, patients with high-grade tumors have a relatively poor prognosis and are not suitable for active surveillance but, as will be noted in this report, often have poor outcomes with any therapy.

    “Under special conditions, some patients with a longer life expectancy may opt for active surveillance as their primary management. This may include patients with very small areas of cancer in their biopsy or patients who, at the time of diagnosis, are reluctant to accept the side effects of potentially curative therapies. If the tumor shows evidence of progression (e.g., increased grade, volume, or stage) while the patient still has a reasonable life expectancy, curative treatments (e.g., surgery or radiation) can be initiated. This can be a difficult clinical decision since signs of progression must be identified before the cancer evolves to a stage (or grade) where therapy is no longer curative. Currently, providing evidence-based recommendations for when to intervene in patients with a long life expectancy are not possible since markers of disease progression are poorly validated.”

    I will argue that it’s hardly a “special condition” for a man with a life expectancy of more than 10 to 15 years to be “… reluctant to accept the side effects of potentially curative therapies.”

    By singling out AS as a “special condition” response to “lower grade, localized prostate cancer … a low risk for clinical progression” for men with a life expectancy of greater than 10-15 years, the AUA is explicitly discouraging AS as a suitable treatment for younger men.

    Come on, Mike, at least in the marketplace of ideas, let’s use the USPSTF trial recommendations to have a conversation without parsing about why the AUA is so reluctant to meaningfully invest in minimizing over-treatment and maximizing resources to bring therapies that are non-invasive and less-invasive to market.

    “…reluctant to accept the side effects of potentially curative therapies.”

    … really… that’s the extent to which AUA will take responsibility for their track record of saddling men, regardless of the need for treatment to save their lives, with impotence and incontinence?

    Real men pay the cost of this intransigence and condescension. They pay for it in their sense of self-worth and self-identity. They pay for it in reduced emotional and physical intimacy in their primary relationships. They pay for it in their mental health status. They pay for it by inviting endless medical intervention into the most private parts of their lives. They pay for it in the very real dollar costs it requires to access the medical interventions not covered by their insurance.

    I’m tired of hearing excuses and rationalizations about why it’s okay to cause these consequences in the 11 of 12 (or 49 of 50, or 89 of 90 depending on whose analysis you look at) men who were never at risk of dying of prostate cancer in the first place. The ratio of collateral damage to lives saved is too far out of balance for the treatment community to continue such complacency. It’s just not acceptable.

  14. Rick:

    (a) Tracy is female.

    (b) We’re splitting hairs. A specific recommendation to an individual after a discussion of all the options is one thing. A general recommendation that all younger men with low-risk disease go onto active surveillance is quite another, and would require some more compelling data if you want to see it in (for example) the NCCN guidelines.

  15. Tracy:

    Don’t yell at me. … I’m not the “enemy.” … I agree with you.

    I am, however, a realist! As I said before, go pound on Gerry Andriole’s door. He has a lot more clout that you may realize! Rick will pound on Peter Carroll’s door for you … but then Dr. Carroll is also in your court … albeit he is a realist too!

    :O)

  16. I’m not yelling at you, Mike, and I know there’s no enemy, just different points of view and priorities.

    I haven’t figured out what it is yet, but something (some event, some compelling piece of research) has to happen, so that someone with gravitas in the prostate cancer community feels empowered to start an explicit conversation about the need to address the epidemic of over-treatment as well as the need for an intensive drive to validate and implement treatment protocols with fewer, less intense, and less permanent side effects. AS and focal therapies have to become the norm for addressing indolent and low-risk cancers, and radical whole-gland therapies have to become the last resort, reserved for treating aggressive, high-risk cancers.

    You can list all these Anrioles, Carrolls, Choos, Klotzs, Barqawis, etc. who know this is true, and yet no one will stand up to lead the parade. The evidence is unequivocal. It’s time for someone to stand up.

  17. We have our next UCSF patients advocates meeting on 11/16. I will ask Stan R. (the chair) to table an item to specifically discuss AS in younger patients with Peter … although I think the UCSF urologists are not reluctant to recommend AS pragmatically; perhaps we can encourage him to raise the issue with the AUA … I am sympathetic.

    BTW, Stan is on the NCCN guidelines committee.

    I do recognize that UCSF is a teaching/ research institution and the private urology practices may not adopt the same standards. We see that in our local Marin practice where AS in all ages appears to be less frequently recommended.

    Apologies Tracy — i now recall dialoguing with you in the past.

    rd

  18. Mike:

    I want to find guys like me too. :-)

    But the truth be told we truly had no reasonable way of knowing that I was a high-risk probability at the age of 44. David Emerson and I were detected when our cancers were Stage 4 and Stage 3B respectively. David at age 42 had metastatic disease at Dx. We weren’t sure with my case after surgery but we have been able to keep it at bay and it is in remission. I feel it’s because a doctor checked the PSA box on a lab blood test sheet without telling me during a routine physical. There is no metric that would have made sense to do that for me even if provisions were added to the USPSTF prostate cancer screening statement concerning risk groups. Again, I had no high risk family history and I was otherwise healthy and asymptomatic.

    I hate to wonder what would have happened in my case if this task force released this recommendation in 2005.

    As far as insurance coverage for testing … I firmly believe that things are going to change if this recommendation goes into effect. It will change for the privately insured and it can easily be changed with a willing Congress for Medicare and Medicaid recipients.

    Interestingly, the USPSTF also announced a draft recommendation calling for heavy reduction in cervical cancer screening, coronary screening, and hearing screening for the elderly. This is just in the month of October.

    Not a good month for me. I have prostate cancer, my mom died of cervical cancer 3 years ago. I’m on blood pressure medication and had a high lipids panel at last check … and if you ask my wife I probably need a hearing check.

    Ugh!

  19. I hear you, Tony; I, too, am not in a high-risk group but was diagnosed with locally advanced disease in 2007 at age 56. I was seeing my urologist for other reasons and he noticed I had not had a PSA for a couple of years. I have a good PCP, but he does not favor PSA testing.

    I will say I had high PSAs in my early 40s on more than one occasion; knowing what I do now, that would have made me far more aware and suggested I was high risk.

    We are now faced with the bigger problem of identifying men with high-risk disease if the PSA is discouraged. I have yet to hear how we do this in the absence of recommendations for mass screening. I feel the interests of this group of men are being dismissed. If you have not heard Snuffy Myers’ rant this week (10/19/11), it is right on point.

    I also spoke up on the air yesterday on KQED’s Forum show that was dedicated to prostate and breast screening.

    Onwards & upwards,

    rd

  20. I agree with Tony C on all points. Laws can be changed and right now if they save $ this makes it is easier. This gives justification to those who want to do just that. I have a problem with evidence-based guidelines when there is a lack of evidence. Mike is right; doctors are hesitant to recommend AS now also because of a lack of evidence. They do not want to harm anyone. Advanced prostate cancer is a harm.

    Coincidentally, I had a doctor’s appointment the week after the release of the draft guidelines. He said he was confused but may stop discussing PSA unless a man asks for information about prostate cancer. Means that we all need to up our outreach to the general community so that men can at least have a discussion with doctors like mine.

    He hasn’t made up his mind yet, but he did say that he did not have time to initiate the discussion any more than he had time to discuss most of the other things he checks for. He also said that if he had a complete discussion about all tests that included pros and cons, his patients would refuse the tests.

  21. Kathy: That doc makes a great point. If I had that conversation with my PCP when he was about to check the PSA box at my physical I don’t know how I would have replied. I felt fine.

    If he said something to the effect of, “Would you like me to run a PSA and screen for prostate cancer? Mind you if you do have a suspicious reading with the test results you may be tempted to treat a cancer that will likely not hurt you but it will likely cause you many side effects,” I might have said “No, I don’t need it, thanks.” I would have made a serious mistake. And then later when my cancer was found because of bone pain or some other symptom, I would have lived with serious regrets and anguish — especially if while getting chemotherapy.

    I don’t believe that the USPSTF has thought this all the way out. But if they make these recommendations, I know the insurance carriers will be very happy. And I do think the government will lessen the financial burden based on dollars … especially today.

  22. Tony:

    I am quite sure that the members of the USPSTF have “thought this all the way out.” However, it is not their responsibility to make decisions about the financial and social consequences of their recommendation, which is based entirely on whether available science supports mass screening of otherwise healthy men (as demonstrated by such clearly defined endpoints as a reduction in mortality compared to other consequences).

    If we don’t want to implement the recommendation for social reasons, that is a separate issue from the validity of the recommendation. The USPSTF recommendation for the less frequent use of mammography is still in place. The government was persuaded not to implement it. If we don’t want this recommendation implemented, then we’d better work out how to persuade Sebelius and others not to implement it! The actual USPSTF “D” recommendation is not going to get changed … and nor should it, although some modifications to the wording might help the situation.

  23. Mike,

    I know we disagree but I find it very interesting that Richard M. Hoffman, MD, MPH, a general internist, is a Professor of Medicine at the University of New Mexico School of Medicine and a staff physician at the Albuquerque VA Medical Center. He also serves as Interim Director for Cancer Prevention at the University of New Mexico Cancer Center. His areas of research interest are prostate and colorectal cancer screening and prostate cancer treatment outcomes, with expertise in clinical epidemiology, health services research, and meta-analysis. He is a medical editor for prostate cancer topics for the Foundation for Informed Medical Decision Making and works with the Foundation to develop shared decision-making tools for prostate cancer screening and treatment of localized prostate cancer.

    He says, “First, I found their interpretation of the evidence to be troubling. I completely agree that screening carries substantial risks for overdiagnosis, overtreatment, and false positive tests. However, we do have data from a large randomized trial (ERSPC) that shows a survival benefit, albeit small. The negative randomized screening trials had important methodological limitations that undermined their validity. Citing meta-analyses that include these flawed studies to argue the lack of benefit is unconvincing. I also found it disingenuous to note that screening does not reduce overall mortality (a point highlighted by the Task Force Chair in the initial news report)–that’s also true for colorectal cancer screening (USPSTF Grade A) and breast cancer screening (Grade B for 50+).

    “Another issue is that the Task Force’s grading seems inconsistent. The USPSTF estimated that over 1,900 women ages 39-49 need to be invited to undergo mammography to prevent one breast cancer death. They cited harm of mammography, including false positive tests, unnecessary additional procedures, and overdiagnosis. With similar harms, ERSPC showed that over 1400 men needed to be invited for PSA testing to prevent one prostate cancer death. Given these trade-offs, I think patients need to engage in informed decision-making about both prostate and breast cancer screening and make personalized decisions that reflect their values–which implies a Grade C recommendation.

    “Finally, the logistics of the ‘don’t ask, don’t tell (unless they ask)’ approach are unclear — and could place unnecessary burden (including medicolegal) on primary care providers.”

    Reasonable people can disagree. Personally I agree with Dr Hoffman.

  24. Two points from the last two comments:

    First, with respect to conversations with doctors prior to PSA screening … I am opposed to these conversations at the time of screening; in my opinion they should occur before a biopsy is scheduled. The PSA test is a simple pin prick and provides information, albeit not the best quality. As long as PSA is regularly monitored, cancer is likely to be identified prior to metastasis, even if a man declines an early biopsy. Once PSA exceeds a certain level, say 20, it is much more probable the cause is malignant.

    Secondly, for Mike … I return to an old conversation we have held; costs should include all costs, including social and opportunity costs, not to mention the economic cost of extended treatment for men with advanced disease. with the high cost of treatments like Provenge now covered by Medicare, this could be significant. I do not believe the USPSTF considers the economic cost of the many high-risk men that will suffer and/or die because a PSA test was not conducted.

    rd

  25. Mike:

    I know this decision is based on the 40,000 foot view and not on the rubber meets the road view such as in my case or in David’s case. In essence the general good of society is to avoid a knowledge that can lead to treatment morbidity, in large part because we haven’t and won’t spend the money on better educating men and doctors. So it is that stopping all screening outweighs extending or saving the smaller number of men that will end up actually paying with their lives.

    I think I get it.

    Where I differ with you is in the understanding that just because the “D” recommendation for mammography has yet to lead to implementation doesn’t mean that it won’t be implemented at some point in the future. Simply put, the timing wasn’t right. Same goes for this one on prostate cancer. And the quite a few others that I hardly see the same level of morbidity (screening for hearing loss, coronary screening with electrocardiograms, PAP screening for cervical cancer, etc) that the USPSTF has sharply taken aim at. No, to me it’s money. The USPSTF might not be making financial decisions even though I question that it never entered their minds, but rather the producers of the “evidence” that they analyze can be easily influenced. Spinning the data for a financial or political purpose is not a new concept. To me to think that eliminating screenings of various disease is not largely cash-based seems very naive.

    If we convince the powers that be now to not implement this recommendation, that will likely change in the not too distant future unless someone shows better data that this is the wrong thing to do.

    And I doubt that government or insurance carriers who pay for screening will spend nearly the same money on that research as has been spent to arrive at where we are today.

  26. Tony … That’s fine … but you can’t blame the USPSTF for that … We never did the trials needed to prove a point that may be demonstrable … that a risk-based forms of screening for prostate cancer in men between 40 and 66 years of age may indeed save lives. The USPSTF draft recommendation just reflects that failure. The trials that have been done have, in general, been done with the intent of proving that early detection and early treatment of all prostate cancer would clearly lower mortality. They have failed to prove this in any meaningful manner.

    I have consistently been saying the same thing, which is that the USPSTF decision is scientifically justifiable. How we act socially on the basis of the USPSTF’s recommendation is a very different issue. I think it would be perfectly reasonable to decide that we needed to do several different things in the face of this recommendation. The one thing I do not think would be reasonable is to go on giving annual PSA tests to every man over 50 years of age. It is clear that the benefits of such blanket population-based screening do not outweigh the risks for over-treatment. … But then I was making that pitch long before the USPSTF issued their new, draft recommendation, as you well know.

  27. Kathy: Another leading primary care physician would completely disagree with Dr. Hoffman, based on his article in the Sacramento Bee over the weekend.

  28. That’s fine …Then I can blame the USPSTF for putting the carriage in front of the horse.

  29. Kathy:

    You, Dr. Hoffman, Dr. Wilkes, and everyone else are entitled to your viewpoints. The fact is that there is great controversy about all this, and I know of no absolutely compelling data for or against the widespread use of the PSA test (as compared to the use of the PSA test as a screening test in carefully selected men who are either at definable risk or show potentially suggestive symptomatology.

  30. Yes everyone is entitled to their own opinion but there are some who have made a career/money being opposed to screening. People like Gilbert Welch, Lisa Schwartz, and Steve Woloshin come to mind.

    If I am reading Dr. Hoffman correctly his emphasis is on informed/shared decision making. He seems to be supporting your viewpoint. Makes more sense for PSA to be graded as a “C” than the “D” USPSTF is recommending now. What they are saying now is that they discourage men from getting a PSA until they have symptoms. That puts more pressure on the legislators to potentially dropping payment for PSA for all men without symptoms. “C” does not make that point so strongly. It agrees with you that appropriate men should be tested. The big problem is that we do not have quality trials/studies to support either side. USPSTF chooses to support the PLCO trial which just about everyone agrees has deep flaws. By the way, Dr. Brawley was part of the team who designed that trial.

    As we reach the point where better tests are working their way through the pipeline the timing for a “D” rating seems to be rather counter-productive. I am not an expert but from what I have read the new tests will probably be expensive and will use the PSA to identify who should or should not get the more expensive test prior to biopsy. If we support what they say then we do not support the idea that “test should be included in the costs of an annual physical for all men > 35 years of age if the patient and his doctor believe such a test is warranted for any reason.” They do say a man should talk to their doctor but should be discouraged even if they are African American or have family members. It does not leave an opening for the men you mention above. This has been Dr. Welch’s mantra for years. He does not believe that anyone should get a PSA or a mammogram. I am not disagreeing with you but I guess I read the recommendation as leading to more complications than you do. The issue is how will it be interpreted in the primary care doctors’ offices since they no longer have to do the education or offer PSA until someone has symptoms and how will it impact insurance coverage in this time of belt tightening? Makes prostate cancer an easy target.

  31. Kathy:

    I understand your anxiety. I just look at the problem very differently to you. As far as I am concerned the entire problem has been caused by the Catalonas of the world — who have, incidentally “made a career/money” out of over-promoting the use of screening based on limited data to an extent that would swamp the revenue of Drs. Welch, Schwartz, and Woloshin combined. The consequence has been an inevitable backlash. It has been coming for years. The results of the PLCO and ERSPC trials were the straws that broke the camel’s back. I don’t actually think that even a “C” grade is justifiable on the basis of the available information. One could reasonably argue for a I statement, but I honestly think that’s the best one might get.

    I am also going to keep gently pointing out that the USPSTF does not “say” some of the things you are suggesting it has said. You are imputing consequences to their statements, and some of those consequences will certainly occur if the prostate cancer community insists on fighting the wrong battle, which I believe they are about to do. The battle we need to fight is not about the USPSTF recommendation at all. It is about the right of a man and his doctor to decide a PSA test is appropriate for him as an individual (for whatever reason), just as the mammography issue was about the right of a woman and her doctor to decide that a mammogram was appropriate for her as an individual. USPSTF is not going to change its recommendation. (They didn’t change their mammography recommendation.) They may make some minor changes to the wording, but that is not where the battle will be won or lost.

  32. Mike a comment on your statement — “The battle we need to fight is not about the USPSTF recommendation at all. It is about the right of a man and his doctor to decide a PSA test is appropriate for him as an individual ”

    I agree with you 100%. However, the point I see being made by Kathy and others is that a “D” grade seriously inhibits this conversation. Doctors, like my own PCP who failed to order an annual PSA, and men, like myself at the time, who only look for an excuse not to get tested, shift their abstention of screening responsibility to the D grade.

    There are many men, like myself, who exhibit aggressive prostate cancer but do not identify any risk characteristics. One strategy to identify high-risk men with no ethnic or family risk would be to mass screen all men once between the ages of 40-45. This would have a double purpose — to help ID high-risk men and to require a one-time conversation between patient and doctor. I say this with the caveat I truly believe that conversation should take place prior to biopsy not prior to PSA testing.

    Bottom line is that the D grade is excessive and discourages valid testing as well as annual mass screening.

    rd

  33. Rick:

    I am not in any way disagreeing with the premise that the “D” grade is going to make the widespread use of the PSA test more “difficult” and subjective. Indeed, I believe it entirely changes the nature of the educational imperative. I also agree that many men would be wise to get a baseline PSA at age 40 to 45 … although I also worry than many could still end up being over-treated on the basis of that baseline PSA. We can disagree over whether that test should occur before or after an appropriate discussion.

    What I am simultaneously stating, however. is that I fully understand how and why the USPSTF justifies the draft recommendation they have issued. I do not believe it will get changed. Because of this, we would be wise to be thinking about what we need to do to live with it as opposed to ranting about its lack of validity. From the point of view of those with extensive expertise in public health and the assessment of population-base screening policies who have been asked to issue a recommendation to the primary care community in the USA, it is an entirely justifiable recommendation. (Please note that I am being very carefully to distinguish between “right” and “justifiable.” And in saying that I do not intend to imply that “justifiable” is either necessarily “right” or “not right.”)

  34. Mike, this is different than the mammogram before 50 issue. That was given a “C”. If we got a “C” I believe the prostate cancer community would be reacting differently. As Dr, Hoffman, an expert in epidemiology said, prostate cancer is being held to a different standard of proof. To me that is the biggest issue.

  35. Kathy:

    Dr. Hoffman is of the personal opinion that prostate cancer is being held to a different standard. He is entitled to his opinion. I don’t think his peers would agree with him, but I am not an expert epidemiologist and I am not going to take sides on this. I am trying to deal with the reality of the situation, not the speculative possibilities.

    You can wish all you like, but the USPSTF clearly gave this recommendation enormous thought. If they considered, for a single moment, that they were going to back down on the decision, they would never have issued a “D” recommendation. The mammogram recommendation was downgraded and the PSA recommendation was downgraded. To that extent it is exactly the same. In theory the “C” recommendation for mammography also implies that it doesn’t have to be paid for in women under 50.

  36. But because it was a “C”, breast advocates were able to justify insurance payment. I don’t think it can be justified under a “D” recommendation. As far as educating men, we can no longer say talk to your doctor. Having a difficult time with what messaging would be?

  37. Kathy … If you insist on seeing the glass as 9/10ths empty, you will most certainly be rewarded with a completely empty glass very shortly.

  38. In my opinion USPSTF group recommendation to stop PSA screening in US is methodologically inconsistent and if fully implemented may lead to serious negative consequences.

    (1) Based on the skewed analysis of six randomized screening trials they concluded that PSA screening provides a little or no benefits. Five of the six trials were poor quality and not supposed to get on the big screen at all. For example, in PLCOST US Trial 92% of control cohort received PSA test either before or during the trial. In addition, more than 50% of screened people with PSA > 4.0 were not subjected biopsy as it was required by the rules. In contrast, two better quality trials reported positive outcomes. ERSPC European Trial showed improvement of mortality and showed that for 1,050 people screened and 49 patients treated one life is saved. Goteborg Trial showed that with 293 people screened and 14 patients treated onr life was saved. Further, recent microsimulation modeling study comparing 35 screening strategies predicted possibility of further improvement of screening performance resulting in one saved life per 262 screened and 9 treated men.

    (2) They disregarded evidence from population-based SEER data showing significant improvement of mortality and relative survival(+45%) in PSA era and the fact that due to PSA screening 85% of all cancers diagnosed as localized curable disease as opposed to less than 50% before introduction of the screening.

    (3) They fail to analyze and discuss results of important Swedish observational trial providing important insight into 21-year-long natural history of not screened and untreated patients with localized and non-metastatic cancer. The trial demonstrated progression in 40% of study population, associated with sufferings and cancer-related death in 16%.

    (4) They stated that the optimal treatment for the cancer is not defined despite overwhelming evidence otherwise. Hundreds of clinical trials demonstrated once and again high effectiveness and safety of different modalities of the treatment in various clinical scenario. AUA, ASTRO and NCCN guidelines provide detailed recommendations for different risk categories and special cases. QA protocols are enforced by peer review and governmental organizations. Did they think that many options means absence of optimal therapy and expected one therapeutic solution for all? If they did it would be rather an utopian view.

    (5) USPSTF correctly described problems with PSA statistical performance (relatively low sensitivity and specificity depending on PSA cut-off point and 20-25% of negative biopsies resulted from false positive tests), harms from biopsy and from different therapies (over-treatment and complications). That’s right, the screening is not perfect and will never be. Any medical intervention marries with negative consequences. People died of aspirin therapy and appendicitis. A lot of things may go wrong. And we all pay a price: failure to detect lethal cancer on one hand and subject a patient with latent cancer to complications from therapy. It was estimated that 20 to 40% of the patients fall into this category. Such scenario might be mitigated by active surveillance. But only partially because we can’t surely know individual history of prostate cancer at this time.

    So, with this limited scientific background and in the absence of better alternative strategies for early cancer detection, on what logic one would recommend to dismantle existing system, undermine its obvious historical progress and expose the population to late diagnosis and higher risk of lethal outcome?

    No surprise ACS, NCCN and AUA continue to recommend the screening at this time. The problem is all three organizations have quite different guidelines and it adds to confusion among primary care providers. It is about time to join intellectual forces and get consensus before it is too late, before USPSTF’s D-graded recommendation is implemented and prostate screening is defunded. HS, chief enforcer of ACA does have such authority.

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