• Erosion of confidence in the confident market solution

    In a prior post I described James Capretta’s plan that could replace Obamacare’s exchanges with lighter-touch regulations. I also wrote that his plan seemed to be identical to that offered by Yuval Levin and Ramesh Ponnuru. An essential, common feature of the approach offered by these gentlemen is that they do not include competitive bidding. That is, the premium subsidy for consumers in the individual and small-group markets would not be a function of market premiums; it’d be a flat tax credit.

    To these authors, I presume this is a feature. By stepping away from the competitive bidding design of the Affordable Care Act’s (ACA’s) exchanges — in which subsidies are tied to to the premium of the second cheapest silver rated plan — their proposal does not require an administrator to take and manage bids from qualified plans. With this obviation, many regulations fall away. The market is unleashed! (To be fair, a few, other regulations would or could be put in their place.)

    And yet, I think a flat tax credit is far from the most efficient design. One should not abandon competitive bidding and exchanges eagerly. The fundamental reason is that we do not know the right level of tax credit. It cannot be determined administratively. Capretta suggests starting levels “of about $5,000 [for families], and for individuals, about $2,500,” and then indexing them “to grow with some measure of inflation.” Is this exactly how much support should be offered individuals and families for purchase of health insurance? Why should it be identical across markets, which exhibit considerable variation in health care costs and premiums? To what measure of inflation should it be indexed?

    Similar puzzles have arisen with respect to Medicare Advantage plans, for which subsidies are set administratively. We know what happened. They shot up well above what plans reported was necessary to provide the Medicare benefit. The ACA was supposed to change that, and to a large extent it did. But the administration also layered on a quality bonus program — the value of which has been questioned by MedPAC and the GAO — that helped keep payments above cost, providing yet another example of the difficulty of administratively setting and maintaining payments at an efficient level. Capretta’s argument against exchanges, which necessarily drove him away from competitive bidding, is that they invite price controls. The lesson from Medicare Advantage is that administratively set subsidies invite bureaucratic meddling too, which is no less damaging to the efficiency of markets.

    Competitive bidding, which I’ve covered extensively, is an alternative to guessing the right subsidy level, as it ties that level to the actual cost of plans (or a plan) in a market. Moreover, if plan bidding is conducted on a market-by-market basis, it permits subsidies to vary with the geographic cost of care. This provides protections for consumers, as it keeps subsidies in line with their actual premium costs; and it provides protections for taxpayers, as it prevents subsidies from running amok, as they have for Medicare Advantage plans.

    One might be concerned that competitive bidding implies a defined benefit, as opposed to a defined contribution (e.g., in the form of a pre-determined tax credit), but it need not. One can retain competitive bidding in a defined contribution regime, though possibly at the expense of the consumer protection I just described. My point is that if one’s interest in a pre-set tax credit, such as that Capretta proposed, is because it’s a defined contribution, one need not abandon competitive bidding to achieve that.

    To be sure competitive bidding requires some additional regulations. Plans must bid their costs for some set of benefits. Thus, one needs to specify a minimum benefit standard and establish standardized plans for the purposes of bidding. But this also aids competition. Choice among many different options that vary in many different dimensions is difficult for consumers. Such an environment weakens competition, as consumers are forced to rely more heavily on inaccurate heuristics. This is the basic premise of a managed competition design, of which competitive bidding a one variant. Exchanges so designed are good for competition and consumers. One can always argue what the minimum benefit and standardized designs should be, of course.

    Perhaps one might be reasonably pessimistic about exchanges, given the poor roll-out of healthcare.gov and some of those in specific states. There’s no denying this has been a disaster. And yet, we also have examples of well-functioning exchanges. Kentucky’s works well, for example. Enrollment in the California exchange has been brisk. Medicare has a perfectly fine, exchange-like environment on medicare.gov for Medicare Advantage and Part D drug plan selection. There are also private exchanges that serve businesses and individual markets. I’m no fan of a big bureaucracy screwing up a large IT project such as healthcare.gov, but I don’t think that condemns the exchange concept; it condemns the administration overseeing that bureaucracy.

    My final concern about abandoning exchanges that harness a competitive bidding design is that I do not find doing so to be a conservative notion at all. For one, we know competitive bidding works. It’s a sound theory that has been tested. Capretta, Ponnuru, and Levin know this. Medicare’s drug benefit program — Part D — has a competitive bidding design that has performed well, and Capretta himself has praised it. The Federal Employees Health Benefits Program also has competitive bidding design elements and has been cited by conservatives, Capretta included, as a model.

    Competitive bidding is also central to any Medicare premium support proposal worth considering. In this context, Levin once called it “the confident market solution.” I agree! With so much evidence of its soundness, and having expressed confidence in it, I’m surprised to see thought leaders for right-of-center policy abandon it. Have they lost the courage of their convictions? If there is a clear line of conservative logic from the confident market solution to an administratively set subsidy, I am not aware of it.

    @afrakt

     
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  • FDA goes after 23AndMe. Wow.

    Wow.

    23AndMe is a home genetic test kit that can give you some answers about your DNA. It’s being marketed as a way for people to see if they have certain traits that might be associated with health risks. One of these is an assessment of the BRCA-mutations that might be associated with breast cancer. The FDA is none-too-pleased with this:

    Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

    In other words, the FDA is sorta saying that 23AndMe is going to get women to get treatment, or even a prophylactic mastectomy when one isn’t needed. It appears that this is because the company is ticking them off:

    The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS.  As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

    However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now nine months later, and you have yet to provide FDA with any new information about these tests.  You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

    Overdiagnosis is a real problem. But these are fighting words. Go read the whole thing. There must be quite a story behind all of this.

    @aaronecarroll

     
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  • The dangers of TV and video games

    From Archives of Diseases of Childhood, “Do television and electronic games predict children’s psychosocial adjustment? Longitudinal research using the UK Millennium Cohort Study“:

    BACKGROUND: Screen entertainment for young children has been associated with several aspects of psychosocial adjustment. Most research is from North America and focuses on television. Few longitudinal studies have compared the effects of TV and electronic games, or have investigated gender differences.

    PURPOSE: To explore how time watching TV and playing electronic games at age 5 years each predicts change in psychosocial adjustment in a representative sample of 7 year-olds from the UK.

    METHODS: Typical daily hours viewing television and playing electronic games at age 5 years were reported by mothers of 11 014 children from the UK Millennium Cohort Study. Conduct problems, emotional symptoms, peer relationship problems, hyperactivity/inattention and prosocial behaviour were reported by mothers using the Strengths and Difficulties Questionnaire. Change in adjustment from age 5 years to 7 years was regressed on screen exposures; adjusting for family characteristics and functioning, and child characteristics.

    RESULTS: Watching TV for 3 h or more at 5 years predicted a 0.13 point increase (95% CI 0.03 to 0.24) in conduct problems by 7 years, compared with watching for under an hour, but playing electronic games was not associated with conduct problems. No associations were found between either type of screen time and emotional symptoms, hyperactivity/inattention, peer relationship problems or prosocial behaviour. There was no evidence of gender differences in the effect of screen time.

    CONCLUSIONS: TV but not electronic games predicted a small increase in conduct problems. Screen time did not predict other aspects of psychosocial adjustment. Further work is required to establish causal mechanisms.

    Since we’re never going to have an RCT of TV or video games, these kinds of prospective cohort studies are important. In this one, they followed more than 11,000 children in the UK. They found that watching TV for three hours or more (a day!) at 5 years associated with a higher chance of having a conduct disorder at 7 years versus kids who watched less than an hour a day. How much of a difference? A 0.13 point increase in conduct problems. That corresponds, according to the article, to “0.09 of a SD [standard deviation] increase in age 7 years conduct score. Do you understand now? I don’t either.

    Anyway, the authors said it was a “small increase in conduct problems”.

    Video games? No effect.

    Yes, these are young kids, and it’s unlikely that they have been playing much GTA 5 or Battlefield 4. So I’ll look forward to more data. But that this point, it’s hard to point to a large study like this and find a smoking gun. Figuratively or literally.

    More on this topic here and here.

    @aaronecarroll

     
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  • Do we really need exchanges?

    Suppose the exchanges of one or more states fail to thrive, as I think is possible, if not likely.* What alternatives might we consider? James Capretta has offered one, the aspects of which I will consider in this post and at least one other.**

    First, you should know that, though I’ll be focusing on the exchange-alternative provisions, Capretta has a full ACA replacement plan, about which you can read in more detail here, here, and here. I’ve already touched on some of its elements in a prior post. Second, though Capretta’s ideas may represent the latest in right-of-center health policy reform — to my eye they appear identical to those suggested by Ramesh Ponnuru and Yuval Levin in the Wall Street Journal — I do not yet believe that Republicans are, in general, anti-exchange. (See also Adrianna’s reaction to the Ponnuru/Levin column.)

    With respect to exchanges, Capretta’s concern is that they require and invite too much government intervention in the market. He worries that the government will, in time, impose price-distorting, Medicare-like payment regulations in the name of cost control. There’s a lot one could debate on this point alone, but, for the purpose of this post, I will accept his premise that this is both likely and undesirable. What’s Capretta’s alternative?

    It has several, interlocking components. First, instead of the ACA’s competitive bidding market design, in which subsidies are tied to the premium of the second lowest plan of some actuarial value (70% or “silver” for the ACA), Capretta advocates a flat tax credit for individual-market and small-group participants. To the extent one wants to get away from exchanges, the virtue here is that there is no bidding and subsidy determination to manage. There is no need to asses which plans qualify as “silver,” and so forth. I see some offsetting limitations, but I’ll defer those to another post.

    Next, there are still some things states would or could do under Capretta’s plan. They would have to manage high-risk pools, to which insurers could refer consumers in order to protect other, less sick consumers from the high cost of covering them in the community-rated design he imagines.

    States would then need to work with insurers to establish a system to identify the truly high-risk cases among the state’s insured population. To prevent abuse, states would need to create disincentives for excessive referrals for high-risk funding, perhaps by penalizing insurers for seeking subsidization for people who are found unqualified.

    States also could (or should? or must?) help their residents manage receipt of the tax credit for which they may qualify.

    The second important role for the states would be reducing the burden that citizens eligible for the tax credit will face when they want to find and sign up for coverage. Specifically, states would need to establish a process by which individuals could make their selection of health insurance, and the state would forward those selections to the federal government so that the credits could be paid directly to the insurance plans chosen.

    Under Obamacare, this process is assigned to a bureaucracy—the state exchanges. But there is no reason a state could not handle this process without ever building a new bureaucracy. For instance, private vendors already facilitate the choice of health insurance in the private market. States could leverage that capacity to build platforms tailored to tax-credit individuals.

    Is this a distinction with or without a big difference? I can’t tell. It’s not clear to me if states would be obligated to facilitate this process in some way or if Capretta is merely suggesting that they might do so. What is clear is that he advocates more flexibility in how they do so than perhaps the ACA currently allows. But this is beginning to sound like tweaks to the current exchange regulations than wholesale replacement of them. One could reasonably debate this point.

    There’s more:

    [S]tates could approach the task of aiding consumer choice by focusing strictly on the transparency and accessibility of the information available to consumers. The states could work with all licensed insurers and brokers to require the standardization of comparison information and then require insurers as well as employers not offering insurance to participate in the broad distribution of that information to the tax-credit-eligible public.

    This really sounds very exchange-like (“transparancy,” “accessibility,” “standardization of comparison information”), though still different from the ACA’s. Moreover, Capretta is clear here that states “could” but not “should” or “must” play this role. Fair enough.

    All in all, this is a different direction than the ACA in terms of states’ roles in managing the insurance market. Is it one that would be an improvement over conditions that might exist in a few (or many?) states in a few years? That, of course, is unclear. As I said, I will return to this subject.

    * I mostly mean too few insurers participate long-term and/or premiums rise rapidly over time. The fact that the federal government is running many state exchanges is not relevant here.

    ** Not sure when, but likely soonish. I’m still gathering information.

    @afrakt

     
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  • Healthcare triage: Turkey Doesn’t Make You Sleepy

    Healthcare Triage #4 is up. What’s Healthcare Triage? Glad you asked:

    Healthcare Triage is a series about healthcare. Dr. Aaron Carroll will explain healthcare policy, medical research, and answer a lot of other questions you may have about medicine, health, and healthcare. Not only that, the videos are going to be pretty fun. John Green will stop in regularly to have his hypochondria soothed by Aaron’s clear and engaging explanations. Healthcare Triage is made by the people who make Crash Course, mental_floss video, and The Art Assignment.

    This one is about the myth that turkey makes you sleepy. It’s a thanksgiving special:

    While Thanksgiving is a time focused mainly on family, friends, and giving thanks, it’s also the cause of a pervasive medical myth: that turkey makes you sleepy. Don’t start with us about the tryptophan. Gah! We know about the tryptophan, and you’re not helping your case.

    It’s your Thanksgiving duty to watch this video and share it with everyone you know. Help us beat down this lie! You owe it to the turkeys.

    Please watch and share! We need support in terms of subscribers and viewers to keep this going!

    @aaronecarroll

     
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  • Reading list

    Enrollment in Medicare Advantage Plans in Miami-Dade County: Evidence of Status Quo Bias? by Anna D. Sinaiko, Christopher C. Afendulis and Richard G. Frank (National Bureau of Economic Research)

    Evidence from behavioral economics reveals that decision-making in health care settings can be affected by circumstances and choice architecture. This paper conducts an analysis of choice of private Medicare plans (Medicare Advantage plans) in Miami-Dade County. We provide a detailed description of the choice of MA plans available in Miami over much of the program’s history and the composition of Medicare beneficiaries in Miami over the 2000s. Our analysis suggests that first becoming eligible for Medicare is the key transition point for MA, and that there is significant status quo bias in the MA market. This consumer behavior has important implications for policy that regulates the MA market.

    Making Nutritional Information Digestible: Effects of a Receipt-Based Intervention on Restaurant Purchases by Kelly Bedard and Peter J. Kuhn

    We study the effects of receipts that include personalized ordering suggestions designed to reduce fat and calorie consumption on purchasing behavior at a restaurant chain. We find that customers, in the aggregate, made most of the item substitutions that were encouraged by the messages, such as substituting ham for sausage in a breakfast sandwich, or substituting frozen yogurt for ice cream, though effects on overall calories and fat consumed were small. The results illustrate the potential of emerging information technologies, which allow retailers to tailor product marketing to individual consumers, to contribute in meaningful new ways to the battle against obesity.

    Reducing Moral Hazard in Employment Relationships: Experimental Evidence on Managerial Control and Performance Pay by C. Kirabo Jackson and Henry S. Schneider (National Bureau of Economic Research)

    Moral hazard is endemic to employment relationships and firms often use performance pay and managerial control to address this problem. While performance pay has received much empirical attention, managerial control has not. We analyze data from a managerial-control field experiment in which an auto-repair firm provided detailed checklists to mechanics and monitored their use. Revenue was 20 percent higher under the experiment. We compare this effect to that of quasi-experimental increases in mechanic commission rates. The managerial-control effect is equivalent to that of a 10 percent commission increase. We find evidence of complementarities between the two, suggesting benefits from an all-of-the-above approach. We also find evidence of incentive gaming under performance pay.

    Coronary Artery Bypass Graft Surgery vs Percutaneous Interventions in Coronary Revascularization: A Systematic Review by Saswata Deb and others (JAMA)

    Ischemic heart disease is the leading cause of death globally. Coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) are the revascularization options for ischemic heart disease. However, the choice of the most appropriate revascularization modality is controversial in some patient subgroups. […] Thirteen RCTs and 5 meta-analyses were included. […] Both CABG surgery and PCI are reasonable options for patients with advanced CAD. Patients with diabetes generally have better outcomes with CABG surgery than PCI. In cases of ULMD, multivessel CAD, or LVD, CABG surgery should be favored in patients with complex coronary lesions and anatomy and PCI in less complicated coronary disease or deemed a high surgical risk. A heart-team approach should evaluate coronary disease complexity, patient comorbidities, patient preferences, and local expertise.

    Subgroup Analyses in Trial Reports Comparing Percutaneous Coronary Intervention With Coronary Artery Bypass Surgery by Stuart J. Head and others (JAMA)

    Subgroup analyses within randomized clinical trials (RCTs) may not be valid, although they may identify important treatment heterogeneity. Reviews of subgroup analyses in primary reports of RCTs have found low credibility due to methodological or reporting issues.2 Subgroup analyses may also be presented in separate reports of extended follow-up beyond the primary end point or specific subgroups of patients.

    Adrianna (@onceuponA)

     
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  • pppp

    Via CHEEZ burger:

    pppp

    @afrakt

     
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  • Facts on Medicare administrative costs

    Holman Jenkins wrote in the Wall Street Journal last night,

    Many on the left tell us the solution is Medicare-for-All, because Medicare is so much more efficient than private insurers, spending a mere 2% on overhead compared to 20% or higher for private plans. […]

    This requires overlooking a lot. Even if overhead-to-medical spending were the right measure, much of Medicare’s overhead is hidden on the books of other agencies, including Health and Human Services, which provides management, and the IRS, which handles revenues.

    Sounds convincing, doesn’t it? But I am not convinced Jenkins has considered all the facts. They’re out there. For example,

    [A] portion of IRS costs are allocated to Medicare’s overhead by OACT [CMS’s Office of the Actuary]. […] [Also,] (1) the Social Security Administration, not the IRS, calculates and collects Part B premiums for the vast majority of Medicare enrollees, and the Railroad Retirement Board does so for former railroad workers; and (2) a portion of the SSA’s and the railroad board’s costs are allocated to Medicare’s overhead by OACT. […] OACT does include the cost of claims processing, which is done by what used to be called “carriers” and “intermediaries” and are now called “Medicare administrative contractors.” […]

    The federal agencies for which Treasury collects expenditure data, and which are therefore included in the trustees’ reports on Medicare administrative spending, include the Treasury Department, the IRS, the SSA, CMS, the Department of Health and Human Services, the Medicare Payment Advisory Commission, the Area Agency on Aging, the Department of Justice, the Federal Bureau of Investigation, and the Railroad Retirement Board (see the appendix). In addition, the appendix lists “quality improvement organizations,” which are private-sector organizations with which CMS contracts. The appendix also indicates that payments by CMS to insurance companies that process claims for Medicare’s original fee-for- service program are included in the trustees’ definition, as are the cost of buildings that house CMS staff and the cost of the numerous demonstration projects Congress requires CMS to conduct.

    This is not just buried in an academic journal article. You’ll find it freely available in my post. I’ve written more on this and other issues relevant to Jenkins’ piece. If you’re interested, read his (Google the title to get it ungated) and then these:

    @afrakt

     

     
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  • Prostate cancer treatment and quality of life

    On this blog, we’ve written a ton about prostate cancer and testing and treatment thereof. A few posts discuss quality of life outcomes (QOL) associated with treatment, like impotence and incontinence. Two papers I read (or reread) recently cover those issues in a particularly helpful way, comparing QOL outcomes between treatment modalities. Moreover, they do so in some fairly comprehensive charts, which I share below.

    First, from “Prostate Cancer: Epidemiology and Health-related Quality of Life,” by David Penson et al. (Urology, 2008) and citing prior work by Tracey Krupski et al. (Urology, 2000):

    5 year QOL

    Next, from “Long-Term Functional Outcomes after Treatment for Localized Prostate Cancer,” by Matthew Resnick et al. (NEJM, 2013), a paper I’ve referenced before:

    QOL svy

    Naturally, mortality is also a relevant outcome, but we’ve covered that extensively, particularly as it pertains to prostate cancer screening. Here’s one such post. Here’s another. All the rest under the prostate cancer tag. But, really, if you’re interested in this stuff, just go read the recent systematic review by Richard Hoffman and colleagues. It’s ungated, but only for a short time. I think it’s awesome.

    @afrakt

     
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  • Quote: Why Obamacare will endure

    [S]ince 2010, [health care insurers and providers] have invested billions of dollars to overhaul their businesses, design new insurance plans and physician practices and develop better ways to monitor quality and control costs.

    Few industry leaders want to go back to a system that most had concluded was failing, as costs skyrocketed and the ranks of the uninsured swelled.

    Nor do they see much that is promising from the law’s Republican critics. The GOP has focused on repealing Obamacare, but has devoted less energy to developing a replacement.

    Healthcare industry officials generally view several GOP proposals, such as limiting coverage for the poor and scuttling new insurance marketplaces created by the law, as more damaging than helpful to the nation’s healthcare system.

    Noam Levey, LA Times

    @afrakt

     
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