• Cost effective doesn’t mean affordable

    NICE is also struggling with Sovaldi:

    The problem is that NICE doesn’t account for affordability in its guidance. One need only consider that the threshold has remained unchanged for over a decade to see that this is true. How to solve this problem really depends on what we believe the job of NICE should be. Should it be NICE’s job to consider what should and shouldn’t be purchased within the existing health budget? Or, rather, should it be NICE’s job simply to figure out what is ‘worth it’ to society, regardless of affordability? This isn’t the first time that an NHS organisation has appealed against a NICE decision in some way. Surely, it won’t be the last. These instances represent a failure in the system, not least on grounds of accountability for reasonableness. Here I’d like to suggest that NICE has 3 options for dealing with this problem; one easy, one hard and one harder.

    The rest is here.


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  • More from Alcoholism and Drug Abuse Weekly on substance use treatment data

    Last week I posted on some content from Alcoholism and Drug Abuse Weekly on the substance use treatment data issue, about which we’ve been writing for some time. Today’s issue includes a story by Alison Knopf focused on the concerns of researchers. A few quotes and editorial notes follow:

    • “The Center for Medicare and Medicaid Services (CMS), at the request of the Substance Abuse and Mental Health Services Administration (SAMHSA), has quietly been scrubbing all Medicaid, Medicare and State Children’s Health Insurance
      Program (SCHIP) files from any information that identified patients who had been treated for substance use disorders (SUDs). The scrubbing began in 2013.”
    • “Historically, CMS research files have not contained any patient-identifying information,” Aaron Albright is quoted. In fact, Research Identifiable Files have been available from CMS for many years. Here’s an example from over 20 years ago of use by researchers of Social Security number and other identifying information to match VA and Medicare claims records. I’m very worried that key people at CMS and/or SAMHSA think that researchers have never had access to identifiable SUD-related claims (the implication being that recent developments aren’t a change). That is false, and if they think otherwise they need to open up some communication with researchers and research organizations. Recent developments are a big change, which is why we’re upset. We’re not pushing for something new. We’re pushing for access to the type of claims data we’ve been able to use for decades.
    • “We asked Albright if the SAMHSA request was documented — he said it was made ‘verbally.’”
    • “The scrubbing was first brought to light in a blog, The Incidental Economist, [in posts] written by Austin Frakt and Nicholas Bagley.” Nicholas is quoted at length, expressing similar thoughts as he’s written here.
    • According to the article, a notice of proposed rulemaking (NPRM) on 42 CFR Part 2 is expected out in 2015.

    I want to emphasize that there is a difference between facilitating linking with patient identifiers and providing wide access to patient identifiers. Researchers require the former, not the latter, and the two are separable. Linking can be done by dedicated, credentialed staff and/or in defined, high security data processing environments to greatly reduce the potential for harm. (This has become relatively standard, in my experience.) Linked files can be subsequently stripped of identifiers for distribution to researchers for analysis. (Though I work with VA-Medicare linked files routinely, I neither obtain nor need (nor want!) patient identifiers in my analytic files, for instance.)

    Moreover, access to claims data for research is not the same thing as access to electronic health records by providers (e.g., in a health information exchange or HIE). Both are important issues, but they should not be lumped together as they require different measures to reasonably ensure patient privacy. For example, for large-scale, observational studies there is absolutely no way to obtain consent from millions of patients over many years for research purposes. HIPAA waivers exist precisely for this reason, but may not be appropriate in the HIE context.

    Full suppression of all substance-use related claims data to research organizations is overkill. But that’s what’s happening. I understand that’s what the regulations currently demand. My concern is that some people are talking about this as if this level of suppression is required for patient protection. That’s simply false. Moreover, it is not an expression of lack of concern for the privacy of such patients to want access to research claims data. It’s an expression of an interest in improving their care. The idea that privacy is the only dimension of potential harm to patients is a disservice to them. Harm can come from not being able to observe the quality of care they obtain and the nature of outcomes it produces, for instance.

    If you can obtain access to it and are interested in this issue, the Alcoholism and Drug Abuse Weekly article is worth reading in full.


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  • I’m not understanding something about PubMed

    Either I’m not getting something or PubMed is missing an important function. It matters for blogging or tweeting a paper’s stable, permanent PubMed URL, its permalink. Do the following to understand the problem:

    1. Google any exact paper title. This will do: “Changes in Quality of Health Care Delivery after Vertical Integration”. One result for this paper is to PubMed: http://www.ncbi.nlm.nih.gov/pubmed/25529312. This is a permalink; that last number is the PubMed ID (PMID: 25529312).
    2. Now go to PubMed itself and do the search again there, dropping the exact title into the search box. It should pull up a unique result and, in doing so, PubMed takes you right to the abstract. For the example above, it’s here: http://www.ncbi.nlm.nih.gov/pubmed/?term=Changes+in+Quality+of+Health+Care+Delivery+after+Vertical+Integration. That’s what’s in the browser URL after the search.
    3. Suppose you want the permalink though, the URL that ends in the PMID. Is there an easy, transparent way to get to it from this PubMed search, namely, a type that has a unique result for which PubMed takes you right to the abstract? As far as I can tell there is not. There is no link on the abstract page that is the permalink.
    4. One way is to notice that the PMID is indicated at the bottom of the abstract page. So, one could paste that into the browser where the “?…” stuff appears in #2 above. This is a brute force approach only people who understand PubMed fairly deeply would understand, but it works.

    My suggestion to PubMed is that it/they turn something on the abstract page into a permalink. The PMID or the paper title would be good places for it — anything obvious and near the top of the page would do. A second suggestion is not to return the full abstract for a search with a unique hit. Instead, return the standard search page (yes, it would have one item), and make the user click into the page with the permalink. Associating the abstract with the wrong URL is just a bad idea.

    I and others have submitted this issue to PubMed. Hopefully, they will fix and this post will become obsolete.

    Update: Other workarounds have been offered on Twitter.

    • Click “Display Settings” in upper right, choose summary, then click on the link on the resulting page.
    • Click on one of the authors, find the paper in the resulting list and click on the link in its title. (I don’t really like this in general, as an author could have a lot of papers and finding the right one could take more time than I’d like.)


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  • Pi, apparently

    Because this is easier to memorize:


    Yes, it’s true. Note that use of the formula requires “base 16 math.” I’m only 20 years behind the news on this one.

    Wikipedia also notes, “For centuries it had been assumed that there was no way to compute the nth digit of π without calculating all of the preceding n − 1 digits.” Yeah, that’s what was holding me back.


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  • The CBO on VA vs non-VA costs

    I only recently learned that in December — perhaps while I was busy stuffing my face with holiday cookies — the CBO published a paper comparing the costs of the Veterans Health Administration with those of the private sector. Here’s a bit from the summary:

    Legislation enacted in 2014 calls for the Veterans Health Administration (VHA) to expand the availability of health care to eligible veterans. That legislation provided temporary funding to expand VHA’s capacity to deliver care and to increase the amount of care purchased from the private sector. […]

    One useful analytic approach [to compare VHA and private sector costs], which was most carefully and comprehensively employed by researchers in 2004, estimates what costs would be if private-sector doctors, hospitals, and other health care providers supplied the same number and types of services as those actually delivered by VHA. Similar to earlier studies, those researchers concluded that the health care provided by VHA generally cost less than would equivalent care provided in the private sector, even though the comparison used Medicare’s relatively low payment rates for private-sector doctors and hospitals.

    The document goes on to discuss a range of important caveats and limitations and includes as thorough a review of the literature on this subject as I’ve seen.


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  • Alcoholism and Drug Abuse Weekly’s coverage of privacy of substance use treatment records

    It has come to my attention that Alcoholism and Drug Abuse Weekly (ADAW) has been covering issues pertaining to the privacy of substance use treatment records for years. Though they make very little reference to the research-related issues and suppression of Medicare and Medicaid data for research purposes (the focus of the blogging by me and Nicholas Bagley), some of the ADAW’s stories in this area include content worth sharing. It’s relevant to the broader context in which those research issues arise. Below are my quotes and, in brackets, my notes and additional thoughts.

    From March 8, 2010:

    • “[In January 2010] a group of lawyers and physicians got together under the leadership of Eric Goplerud, Ph.D., to propose changes to a federal law governing substance abuse treatment records. […] Goplerud’s group recommended
      creating an exception to the requirement that substance abuse treatment programs must obtain the consent of patients before releasing any information about those patients — a requirement codified in the Confidentiality of Alcohol and Drug Abuse Patient Records regulation almost 40 years ago.”
    • [The focus, according to ADAW’s reporting is on the practical and clinical challenges in the electronic medical record age that arise in maintaining the strict confidentiality regulations currently require. Note that, though not unrelated, this is not principally a concern for research with Medicare and Medicaid data.]
    • “A key argument used by Goplerud’s group is based on what they call ‘patient safety.’ They say that health care providers need to know about a patient’s addiction and medication history in order to provide quality care.”
    • “[Faced with opposition from patient advocacy groups, Goplerud] backed down somewhat.” “Passion is high among patient advocates.”
    • “H. Westley Clark, M.D., [then] director of the Center for Substance Abuse Treatment [CSAT] and the agency’s point person on 42 CFR Part 2 [the relevant regulations, described here and in prior posts], cancelled a planned interview with ADAW after CSAT’s parent agency, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a virtual press blackout on the topic.”

    From October 24, 2011:

    • [Supporting Goplerud’s point above,] “Because methadone and buprenorphine can have adverse effects when mixed with other controlled substances, it’s important for OTPs [opioid treatment programs] including office-based physicians dispensing the first dose of buprenorphine to find out whether these patients are getting prescriptions for controlled substances such as benzodiazepines or opioids from other sources, said the September 27 ‘Dear Colleague’ letter, from [then] CSAT director H. Westley Clark, M.D.”
    • [But, contradicting this,] “In the letter, Clark, a lawyer, also said that OTPs should not input data about their patients into the PDMPs [prescription drug monitoring programs], because this would violate 42 CFR Part 2, a federal regulation which protects the privacy of patients in substance abuse treatment.”

    From September 23, 2013:

    • “The secret is out: treatment record confidentiality for substance abuse patients is no longer a sure thing. ‘It’s getting in our way,’ [said] SAMHSA Administrator Pam Hyde.”
    • “SAMHSA has been pressed by many others who have not liked the confidentiality law.” Yet, “[o]ver the course of several years, SAMHSA has steadfastly clung to the law and implementing regulations for 42 CFR Part 2. […] At SAMHSA, the guiding force behind preserving 42 CFR Part 2 has been H. Westley Clark, M.D., [then] director of the Center for Substance Abuse Treatment and a lawyer as well as a physician.”
    • “But more than three years ago, the electronic health record (EHR) that is codified in the Affordable Care Act threatened that regulation.”
    • “Researchers say that their work is ‘crippled’ by the law’s requirements.” [As far as I’ve seen, this is one of the few mentions of researchers, maybe the only one in ADAW’s reporting in this area.]
    • “The regulations in 42 CFR Part 2 were created because patients in substance abuse treatment could be tracked down by law enforcement, even into the treatment programs. It has since served as a kind of guarantee that patients’ names couldn’t be turned over to employers, landlords, police and others without individualized consent. Patients in methadone treatment have relied on it to make sure their regular physicians didn’t discriminate against them and deny them pain medications. […] As articles in this newsletter have repeatedly shown, mothers who are taking legitimately prescribed opioids who give birth to babies with neonatal abstinence syndrome can still have their babies taken away. Homeless drug users, despite the administration’s Housing First policy, can still be denied subsidized housing. Legislatures across the country are calling for drug testing for welfare recipients. If the confidentiality of patient records is taken away, on the eve of healthcare reform, will that have a chilling effect on people’s decision to seek treatment? [… Without adequate protections,] [p]eople will avoid care, and the consequences will be felt by the larger community. Untreated problems beget more problems, [Dr. Clark said.]” [The problem is, if research is hampered, care suffers too. I’m sympathetic to these privacy concerns, but I do not think that preventing researchers’ access to taxpayer-funded Medicare/Medicaid treatment data — with strict privacy protection protocols and penalties for breaching them — is necessary. There has got to be another way.]

    From October 21, 2013:

    • “Renee Popovits, principal attorney with Popovits and Robinson, an Illinois-based law firm specializing in substance abuse treatment providers, is one of the leaders of the group that believes it’s time for a change in 42 CFR Part 2, the 40-year old regulation governing the confidentiality of alcohol and drug abuse treatment records. Specifically, the part of the regulation that requires patients to give individualized consent for each record release, stating to whom it is to be given, is not realistic given the technology of the Health Information Exchanges (HIEs), Popovits told ADAW.”
    • [I’ve read that a similar problem arises for ACOs. In particular, they cannot see the substance use-related treatment from non-affiliated providers the cost of which they’re held accountable. Something is not right about that. Again, this is not principally a research issue, but clinical and health system financing ones.]
    • “[W]hy do we have 42 CFR Part 2 and not something similar for other conditions?”

    June 16, 2014

    • “The confidentiality regulations governing medical records for the treatment of substance use disorders (SUDs), in force for more than 40 years, are being called into question by almost everyone in health care except for patient rights advocates.”
    • “[P]atients are losing in the battle.” [This is terrible and wrong framing, even if patient advocacy groups feel that way. Nobody wants patients to lose. We want them to be reasonably protected while also helping their providers offer the best possible care and researchers to be able to do the work to improve that care. It’s not that patients do not deserve and need protection, it just has to be provided in a different way. The regs are outdated.] “The 42 CFR Part 2 regulations were first issued in 1975, and were last amended in 1987.”
    • “Under 42 CFR Part 2, a patient must give explicit, written consent each time SUD treatment records are released; the consent must include to whom the records are released, and be for one time only.” [There are several problems: “written” is not information-age friendly, depending on interpretation; “to whom” can be a huge hurdle, since patients don’t always know exactly who their doctors are or will be; “one time” is also problematic.]
    • “Four years ago, SAMHSA unequivocally said it wouldn’t change them [the regs]. In an August 4 public meeting on 42 CFR Part 2 that same year, Pamela Hyde, administrator of SAMHSA, and H. Westley Clark, M.D., director of SAMHSA’s Center for Substance Abuse Treatment, reiterated that 42 CFR Part 2 would not be revised in any way []. Since then, there have been indications that all is not well with SAMHSA and the confidentiality regulations.”
    • “One common thread among the commenters who favor changing the regulations is that they promote stigma [because they single out substance use disorder as distinct from other medical conditions].”
    • “Others in favor of revising the regulations are Richard Rosenthal, M.D., from the American Academy of Addiction Psychiatry; Mark Jones of SmartNet in Oklahoma; Eric Goplerud, Ph.D.; Al Guida of Netsmart; Oregon Behavioral Health; Maine-Health; Renee Popovits; many IT vendors; and more.” [Yes, I think at this point you can add many top researchers, among others, to this list.]
    • [This issue includes long sections on civil rights and discrimination issues that I’m not quoting, but are worthwhile background. I stipulate that these are important and relevant. I do not believe that they imply researchers should never work with substance use-related claims data without consent (since that’s impractical for the millions of records I’m talking about).]
    • [OK, one quote:] “The entire health IT system is now ‘designed for surveillance.'”

    October 6, 2014

    • “The short story is the sudden retirement, effective October 3, of H. Westley Clark, M.D., who for the past 16 years has been the director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA).”
    • “[H]e has been on the wrong side, politically speaking, of the debate on 42 CFR Part 2″


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  • JAMA Forum: For second line diabetes medications, an observational study goes where RCTs haven’t

    My latest JAMA Forum post is about a recent study that found that a common diabetes drug causes harm. I discussed this study previously, but my JAMA Forum approach is more tutorial about methods. I encourage you to read it. And, I welcome your feedback, as noted at the end of the post.


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  • What are the big health policy problems, and what can med students do to prepare to solve them?

    Those are some of Allan Joseph’s questions. Go over to Project Millennial to give him your answers.


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  • Social impact bonds to address social determinants of health

    “This is not a blog post.” —René Magritte

    Of course that’s a joke. My point is that I have been intending to write a piece about this subject for long enough to know that I’m unlikely to every actually write it. Below are the bits I’ve pulled together. This, more-or-less, has been sitting in my post draft workspace for over two months. If you want to take the following (or even a part of it) and write something, good for you! Let me know when you do! Otherwise, I may someday come back to this, but I wouldn’t bet on it.


    • There’s more to health than health care. Estimates vary, but social determinants and environmental factors play a substantial role. [One side interest/task is to go through the linked document and see if there’s really anything new in it or that which it cites that Adrianna and I did not cover in our prior digging into social determinants. See this FAQ.]
    • Relative to other countries with better health outcomes, we spend a much higher proportion on health care than on other social services. This might explain why our health outcomes are so much worse (Taylor, Bradley). Our spending is not allocatively efficient.
    • If this is indeed the key, the straightforward thing to do would be to reallocate spending from health care to other social services.
    • This may be politically hard. [Why? Need to get to the notion that people are skeptical of the benefits of social services spending or otherwise unwilling to fund, if true.]
    • Another approach, perhaps more politically viable, are social impact bonds. Examples in a 2014 Health Affairs paper.
    • Can they scale up? Should they? Consider the effort and planning. Consider the capital requirements, the motivations of investors. Consider the challenges of finding good implementers. Consider the distortions and benefits of needing short- to medium-term, quantifiable outcomes (5-7 year horizon?).  Consider the difficulties of finding good comparators, of study design.
    • What happens after a successful project? What should happen?



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  • I’m losing patience with mint.com

    I don’t ask for much, really.

    I’d like to be able to access a key subset of my financial transactions, displayed in comprehensible form, all in one place, from anywhere, via my phone, iPad, or a desktop/laptop. Mint.com claims to do that.

    I’d like to be able to enter pending transactions (e.g., checks written) and then have them automatically reconciled when they clear. Mint.com claims to do that.

    When I have a problem — especially a longstanding one — with an account, I’d like tech support to engage and solve that problem. Mint.com claims to that.

    Only, mint.com has woefully failed. Forever, one of my accounts fails to reconcile checks. I can sort of live with that, doing it manually, but I shouldn’t have to.

    About this problem, tech support has been of no help. Actually, the latest communication about this by them is nonsensical. Checks won’t reconcile unless they match check number, amount, and date, they say. The first two are perfectly reasonable. The last is ridiculous. I enter the check on date written. It clears days to months later. Those are two dates that will never, ever be the same. There should be no attempt to make reconciliation contingent on them matching.

    (Note, the account that has this problem is with one of the largest financial institutions in the U.S. This is not some obscure, strange account. And many other accounts reconcile checks, so clearly tech support is not making sense.)

    But it’s worse. A few months back, transactions in this account started showing up with blank descriptions. Tech support has been unable to solve that. But, in trying to, they deleted a big batch of my pending transactions (entered checks, not yet cleared). So, now I have no idea what’s outstanding.

    This is a disaster, and I’m fed up. I’ve lost hours of time cleaning up after mint.com’s failures. Is there any free (or cheap) service that can handle what I want, as articulated above? Is this so hard?

    In the meantime, I’m going back to spreadsheets. They work, I understand them, but they don’t automate as much as mint.com claimed to automate.

    Then again, mint.com seems to suck. So …

    Update: Since writing this post I tried Yodlee Money Center. I don’t like it for two reasons. First, interacting with it requires far too many clicks. Second and more importantly, it fails at a basic function: It doesn’t report the difference between one’s cleared (posted) balance and one’s balance accounting for pending transactions (e.g., checks not yet cleared). This is fundamental. Without it, one can’t tell whether one had the funds to accommodate pending checks. All of this makes me wonder if people who design electronic checkbooks actually use them. I’m sticking with a spreadsheet until something better comes along, including possibly a patched-up mint.com.

    Update #2: I just gave Moneydance a try. First of all, it costs $49.99, though there is a trial period. In attempting to take advantage of the trial period, I could not get it to interface with my bank, despite it being a major financial institution. The set-up wizard type thing just didn’t work. I got stuck. Sure, I could engage tech support yadda yadda yadda, but I’m not interested in anther product that requires troubleshooting for basic functions. Back to spreadsheets!


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