Starting August 6th, the Notice of Observation Treatment and Implication for Care Eligibility Act, or NOTICE Act, will go into effect. This new law requires hospitals to give written and verbal notice to Medicare beneficiaries who have been on observation status for more than 24 hours.
What is observation status? In a nutshell, observation status is a term hospitals use to bill Medicare. Observation status is based on a doctor’s medical determination. Doctors place patients on observation status if their condition is not serious enough for inpatient admission status, but still requires monitoring in case health worsens.
The NOTICE Act is a step in the right direction because patients are often unaware of their observation status or its potential consequences. Prior to the NOTICE Act, the only way to know your status was to ask. Part of the reasoning behind the law is that beneficiaries get hit with serious financial consequences including higher than expected hospital bills and that Medicare won’t cover skilled nursing care needed after discharge from the hospital. However, the law could do better to prevent those consequences.
The issue for many patients is that being on observation status also means they are classified as an outpatient, not an inpatient. That means that rules for Medicare Part B (outpatient services) and D (prescription medication coverage) apply to their hospitalization rather than part A (inpatient). To understand this better, see this comparison chart
Oftentimes, Medicare beneficiaries learn about their observation status when arranging for the skilled nursing facility care they need after discharge. These patients make the very valid assumption that because they are wearing hospital gowns, in a hospital bed, eating hospital food, meeting with nurses and taking tests administered by doctors that they are an inpatient. They learn their actual status, and its consequences, too late and have little recourse. How could the law be improved?
An appeal process is needed. The NOTICE Act ensures people know about their observation status and the financial consequences of this determination. And that’s it. They don’t know the medical reasons a doctor made the decision and they aren’t given any avenues to appeal this determination. Patients will be informed of their observation status and the possibility of higher medical costs, but have no recourse to fight the decision.
Use plain-language in the notice to ensure comprehension. The Medicare Outpatient Observation Notice, or MOON, used to inform patients about their observation status is not written using easy-to-understand language. In its current form, the MOON is written for a 12-grade reading level, a break from the common practice of writing consumer materials for no more than an 8th grade reading level.
Do you agree Medicare patients deserve more?
Tell the federal government. They are asking for your comments right now in response to the proposed rules. You can use this comment template or submit comments on your own. Submit your comments with these simple steps:
Go to the website where comments are submitted. Enter the phrase "Medicare Program: Hospital Inpatient Prospective Payment Systems" in the search box. The first hit will be the rule you want to comment on. Click the "Comment Now!" blue box.
Use our comment template to show how people you know have been hurt by observation status and why changes need to be made by including personal information where indicated with yellow highlights. Adding specific examples of real people makes your case more compelling.
You can also write your own feedback directly in the comment box.
Go ahead, make your voice heard! The greater number of people that speak up, the more likely changes will be made.
How can you get ready?
While the law could be improved, it will be implemented August 6th. Prepare for the changes by getting informed:
Read the notice, which will be standardized, before hospital staff hand it to you.
Going to the hospital is already stressful. Deciphering complex notices, understanding jargon and dealing with unexpected medical bills increases the strain. Armed with knowledge, you can act as a more effective advocate for yourself, your clients or patients, and loved ones so they can focus on their health and recovery.
Transparency International (TI) defines corruption as
Abuse of entrusted power for private gain
In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.
the scale of corruption is vast in both rich and poor countries.
Also,
Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.
The report did not get much attention. Since then, health care corruption has been nearly a taboo topic in the US. When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries. On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.
Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here). But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries. Health Care Renewal was practically the only source of coverage in the US of the survey's results.
Transparency International's New Report on Corruption in the Pharmaceutical Sector
Now Transparency International (TI) has tried, and Health Care Reenewal will try again. In June, 2016 Transparency International published a new report entittled
Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.
In my humble opinion, the report is particularly significant in that it classifies as corrupt various kinds of activities that occur within the pharmaceutical sector (and also in other parts of health care) which are often discussed publicly as anything from standard operating procedure through unfortunate errors to unethical behavior. These include many activities which we have frequently discussed on Health Care Renewal. For example,
We have frequently discussed how pharmaceutical companies, and biotechnology, medical device, and other health care companies and organizations, may manipulate clinical research to enhance the likelihood that is results will favor their products and marketing goals, even if the results are biased, inaccurate, could mislead physicians and patients, and ultimately harm patients. The TI report included:
As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients.
We have frequently discussed how health care organizations (as above) may outright suppress clinical research when the results fail to support their interests. The TI report included:
Transparency and access to information through mandatory clinical trial registration, sanctions for not registering results or providing clinical trial information, and the publication of both positive and negative results are commonly discussed as helpful tools to curb corruption. With the European Medicines Agency (EMA) as a notable positive exception, public agencies and authorities do not require R&D-based pharmaceutical companies to make their raw data publicly available, making it impossible to verify whether the reported results are accurate. Based on laws and regulations clinical trial data is considered to be proprietary information, which allows pharmaceutical companies to conceal important data from the public domain.
Manipulation of the Dissemination of Clinical Research
We have frequently discussed how health care organizations may manipulate the dissemination of clinical research, through various forms of publications, presentations, courses, media summaries, etc, to favor their products and marketing goals, even if the results are misleading and could harm patients. For example, a while back we discussed the problem of "ghost-written" articles appearing in scholarly journals. The TI report included:
The practice of ghostwriting is also a risk with clinical trials. Ghostwriting involves the writing of clinical trial publications by industry and then having a highly esteemed researcher pass these findings off as their own without disclosing their actual involvement with the authorship of the article. It is a common practice, particularly in industry led trials. Ghostwriting is done to increase the prestige and reputation of the findings, while simultaneously researchers are able to improve their reputation, which can lead to promotions. Clearly this practice can result in inaccurate results being published.
Deceptive Marketing
We have frequently discussed how marketing of pharmaceuticals (and nearly everything else in health care) may be deceptive, favoring companies' products and services, but again misleading health care professionals and patients, and ultimately risking patient harm. In the extreme, pharmaceutical companies (and other health care organizations) may resort to bribes or kickbacks. The TI report included:
There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company’s medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences.
Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors’ prescribing habits and encouraging off-label, unlicensed use to increase sales.
Again, while the report summarizes information that is likely familiar to most Health Care Renewal readers, what is striking is that it describes manipulation of clinical research, suppression of clinical research, manipulation of dissemination of clinical research, and deceptive marketing as corruption. That is a sentiment rarely heard in the US, and one that appears nearly taboo.
Demonstrating the strength of the taboo, this striking report has gotten almost no attention in the media or scholarly medical and health care literature in the developed English-speaking countries. Let me note the important exceptions, however.
I learned of the report from a brief news item from the BMJ, the prestigious UK journal that seems most at the forefront of championing the integrity of medical and health care research.(1) The only substantial news article I could find on the report was also from the UK, in the Independent. Its sub-title is worth repeating:
Transparency International says corruption is making a few rich and wrecking the health of some of the world's poorest people
Also, there were brief articles in Reuters, and in (web-only) FiercePharma. That is about it so far.
The report itself suggests why it has been so anechoic, just like nearly every other attempt to expose health care corruption to public discussion. Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure. In the TI Report itself,
However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.
Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks. It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.
I might as well repeat myself once again. As I wrote in 2015,
If we are not willing to even talk about health care corruption, how will we ever challenge it?
So to repeat an ending to one of my previous posts on health care corruption.... if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption. Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage. Yet such action cannot begin until we acknowledge and freely discuss the problem. The first step against health care corruption is to be able to say or write the words, health care corruption.
Reference
1. Torjesen I. Group calls for more to be done to tackle corruption in the pharmaceutical industry. BMJ 2016;353:i3099. Link here.
Your smartphone allows you to get almost instantaneous answers to the most obscure questions. It also allows you to waste hours scrolling through Facebook or looking for the latest deals on Amazon. More powerful computing systems can predict the weather better than any meteorologist or beat human champions in complex board games like chess.
But for several years, economists have asked why all that technical wizardry seems to be having so little impact on the economy. The issue surfaced again recently, when the government reported disappointingly slow growth and continuing stagnation in productivity. The rate of productivity growth from 2011 to 2015 was the slowest since the five-year period ending in 1982.
Healthcare becomes the gravamen of the article:
One place to look at this disconnect is in the doctor’s office. Dr. Peter Sutherland, a family physician in Tennessee, made the shift to computerized patient records from paper in the last few years. There are benefits to using electronic health records, Dr. Sutherland says, but grappling with the software and new reporting requirements has slowed him down. He sees fewer patients, and his income has slipped.
Unfortunately, the advisors who helped him with the article may have provided incomplete information:
... “The government funding has made a huge difference,” said Dr. Ashish Jha, a professor at the Harvard School of Public Health. “But we’re seeing little evidence so far that all this technology has had much effect on quality and costs.”
Why would anyone expect (good) effects on "quality and costs" of healthcare when the technology is so unfit for purpose in design and implementation that it has alienated most of its users?
... "I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."
I do not think "political appeal" is a good justification for a multi-billion dollar cybernetic experiment in medicine, where the risks of the technology are considerable and where basic healthcare needs are not being well met among the poor and underprivileged.
Former ONC Chair David Brailer is quoted:
“People confuse information automation with creating the kind of work environment where productivity and creativity can flourish,” said Dr. David J. Brailer, who was the national health technology coordinator in the George W. Bush administration. “And so little has gone into changing work so far.”
Brailer was little better than Jha, and moves the goalposts with a type of circular logic. He appears to be saying that technology that will revolutionize medicine can't work until we change how things are done in medicine so the technology can revolutionize medicine.
The article then quotes one Tennessee physician, a Dr. Sutherland, who is "happy" to accept bad health IT, a resultant pay cut, and increased work:
... Today, Dr. Sutherland’s personal income and the medical group’s revenue are about 8 percent below where they were four years ago. But in 2015, both his earnings and the revenue of Healthstar, which employs 350 people in 10 clinics, increased slightly, by nearly 3 percent from 2014.
... Dr. Sutherland bemoans the countless data fields he must fill in to comply with government-mandated reporting rules, and he concedes that some of his colleagues hate using digital records. Yet Dr. Sutherland is no hater. Despite the extra work the new technology has created and even though it has not yet had the expected financial payoff, he thinks it has helped him provide better information to patients.
He values being able to tap the screen to look up potentially harmful drug interactions and to teach patients during visits. He can, for example, quickly create charts to show diabetes patients how they are progressing with treatment plans, managing blood glucose levels and weight loss.
He is working harder, Dr. Sutherland says, but he believes he is a better doctor. Blunt measures of productivity, he added, aren’t everything. “My patients are better served,” he said. “And I’m happier.”
While being able to provide fancy charts and check drug-drug interactions (for which a massive and expensive EHR is certainly not needed; a PDA will suffice) is fine.
However, anyone who gladly accepts a pay cut, and inconvenience, and harder work due to bad health IT, and is a happy camper with that state of affairs, either suffers from the Stockholm syndrome or has a lot of discretionary income and free time to spare that many clinicians do not.
From: S Silverstein To:Steve Lohr Date: Tue, Jun 7, 2016 at 10:02 AM Subject: Re: Why the Economic Payoff From Technology Is So Elusive
Dear Mr. Lohr,
In medicine, the answer to this question is straightforward. I don't know if Ashish Jha brought this to your attention, or if he himself is aware of it.
This letter from nearly 40 different medical societies to HHS about bad health IT is specific about how bad the current health IT is:
You should be aware of the letter's contents. I've also attached it to this email.
In academic Medical Informatics, such matters are often ignored, as they run contrary to the narrative that IT will "revolutionize medicine"; I know, as I was Yale faculty in Medical Informatics myself.
The assumption in academic circles and in the Administration (unfortunately) is that "all health IT is good health IT."
Unfortunately, it is not. From my own site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/ :
Definitions authored by myself and Australian informatics expert Dr. Jon Patrick:
Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.
Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, is lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.
It comes as no surprise not to find productivity gains, but instead hundreds of thousands of angry physicians (and nurses), when health IT is mostly bad IT.
The health IT industry itself needs serious remediation before its products will be a boon to medicine.
Background: Untrustworthy Clinical Practice Guidelines
Since the 1990s, clinicians have been exhorted to follow clinical practice guidelines (CPGs) to improve their decision-making and patients' outcomes. When Dr Wally Smith and I started teaching a short course (often at the Society for Medical Decision Making meetings) about changing physician behavior, we naively set out to improve decisions by increasing adherence to such guidelines. We first thought that physicians' apparent shortcomings in guideline adherence were due to their lack of knowledge of the guidelines and the underlying evidence, and to their human cognitive limitations.
That approach, however, failed to yield ways to improve adherence. After a while, it occurred to us that there might be other reasons physicians did not follow guidelines, including their lack of trust of the guidelines or the evidence supposedly incorporated within them. We learned that integrity of the clinical evidence base has been severely degraded due to the manipulation of clinical studies by those with vested interests, and the outright suppression of trials for which manipulation does not produce the desired results.
Furthermore, as we became less naive, we learned that the integrity of the guideline development process was also suspect, again due to the influence of those with vested interest. No wonder physicians were suspicious of guidelines, and resisted adhering to them.
In 2011, the prestigious Institute of Medicine released a report on the development of better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust. Link here.) We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect. The IOM report cited conflicts of interest (COIs) affecting the guideline development process as a major reason such guidelines might be untrustworthy, and suggested a variety of ways to reduce COIs affecting guidelines.
These included in particular: - Guideline committee members should disclose their conflicts of interest in detail, and these should appear in the guidelines (Standard 2.1, 2.2) - The number of conflicted committee members should be minimized, and in no case should be a majority of the committee (2.3, 2.4) - Funders should have no role in guideline development (2.4)
This week, an original article(1) and editorial(2) in PLoS Medicine discussed how guidelines published since the report was produced addressed conflicts of interest.
Article Summary
Below I summarized the article, but presented results somewhat differently than did the authors.
Design
Campsall et al did a cross-sectional study of clinical practice guidelines that appeared in the US Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse in 2012 from national or international organizations, excluding guidelines produced by organizations restricted to allied health professionals, guidelines produced by corporations, or guidelines that had no specific recommendations. They obtained information from the guidelines, the organizations' websites, and surveys sent to the organizations.
Study Population
The study population was 290 guidelines produced by 95 organizations. The response rate for the surveys was 68%. The organizations were primarily professional societies (67%) or disease advocacy groups (21%).
My comment is that therefore this study assessed guidelines mainly produced by non-profit organizations which ostensibly uphold health care professionals' values and/or primarily support patients' interests.
Industry Funding
63% of organizations reported receiving funds from biomedical companies. (It was not clear whether the remainder denied receiving such funding, or provided no information about funding.)
My comment is that the majority of such ostensibly "do-gooder" organizations are nonetheless at least somewhat supported by commercial firms that market health care products, presumably mainly drugs or devices.
Conflict of Interest Policies
Please note that the authors provided results to emphasize the positive, for example, they provided the proportion of organizations which provided specific types of information about COIs or had particular policies to reduce COIs. In most cases, I simply did subtractions to emphasize the negative. Furthermore, the authors further emphasized the positive by choice of denominator, as noted below.
20% of organizations did not provide any information about conflict of interest policies, and 7% asserted the existence of such policies, but did not disclose them. A majority, 55%, did not have disclosed policies that specifically dealt with with conflicts of interest affecting guidelines.
My comment is thus that a majority of these do-gooder organizations did not apparently even begin to address, at least in terms of clear, transparent written policy, the recommendations of the IOM report on trustworthy guidelines.
Measures to Improve Guidelines Trustworthiness by Decreasing Influence of Conflicts of Interest
The authors provided the number of organizations with disclosed policies that addressed particular issues of concern to the IOM in their report on trustworthy guidelines, but made the proportions of such organizations seem larger by using as a denominator the number of organizations that disclosed their entire policies, rather than the total number of organizations which produced the guidelines.
Therefore, they found that of the 60 (out of 95 total) organizations that fully disclosed their conflict of interest policies: 98% required committee members to disclose conflicts of interest; 90% required review of conflicts of interest before guideline publication; 68% required that a majority of guideline committee members be free of conflicts of interest; 92% reported publishing committee members' conflicts of interest within guidelines; 78% did not allow direct industry funding of guideline development 82% did not allow industry participation in selection of committee members 67% did not allow industry to review guidelines prior to publication.
That all sound good, but consider what happens when one uses the total sample of organizations in the denominators.
Therefore, the article also found that of all 95 organizations that produced the guidelines of interest:
38% did not require CPG committee members to disclose conflicts of interest 43% did not require review of committee members' conflicts of interest prior to guidelines development 57% did not require that a majority of guideline committee members be free of conflicts 44% did not report publishing committee members' conflicts of interest within guidelines 48% did not report preventing direct industry funding of guidelines 51% did not report preventing industry participation in selection of committee members 61% did not report preventing industry review of guidelines prior to publication.
My comment is that thus the results suggested that substantial numbers of organizations that produced CPGs did not demonstrate that they were committed to measures that would improve guidelines trustworthiness by reducing the influence of conflicts of interest.
Disclosure of Conflicts of Interest Within Guidelines
Again, it was necessary to recalculate some proportions using the full population of guidelines reviewed as the denominator.
Of the 290 guidelines reviewed: 65% "included disclosure statements regarding direct funding and support" 37% specifically disclosed the absence or presence of direct funding from biomedical companies However, 49% did not disclose committee members' financial relationships 99% did not disclose relevant financial relationships of the organization (that is, institutional conflicts of interest) that produced the guidelines as a whole
My comment is that substantial numbers of published guidelines were not clearly produced so as to increase their trustworthiness by reducing the influence of conflicts of interest on them.
Did the Guidelines Follow the Organizations' Stated Policies?
The authors commendably provided information about whether the guidelines produced by organizations that disclosed conflict of interest policies followed those polices. They found:
16% of organizations "that reported that committee member conflicts of interested were published in guidelines" produced guidelines that did not include committee members' COI disclosure
61% of organizations that "reported the majority of committee members must be free of conflicts of interest" produced guidelines by committees with majorities of conflicted members
6% of organizations that "reported that industry partners were not permitted to directly fund clinical practice guideline development" produced guidelines which disclosed such funding.
My comment is that thus even of the organizations that stated they had policies in place to improve the trustworthiness of the guidelines they produced by reducing the influence of conflicts of interest, they allowed guidelines to be produced that did not follow those policies.
Authors' Conclusion
Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appear to be common. These relationships are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers. We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies.
Editorialists' Conclusion
The editorial by Bastian(2) was sharper in tone. It included an observation that reinforced my confession of naivete above:
With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It seemed so self-evident, it got barely a mention even in national policy on guideline development
She also noted that the Campsall study did not address all the ways conflicts of interest can influence guideline development:
Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients’ organizations.
She noted that the failure of guidelines to report their developers' conflicts of interest is a continuing problem. The rate of failure to report found by Campsall et al was
about the same rate that Taylor and Giles found in 2004 and Norris and colleagues found in 2010.
Finally, she emphasized that we are still a long way from having guidelines that health care professionals and patients can trust:
Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it’s a case of caveat lector: let the reader beware.
My Summary
So should physicians trust clinical practice guidelines? At least this article suggests they ought to be very very skeptical of them. The IOM report meant to improve the trustworthiness of practice guidelines seems to be honored mainly in the breach. The likelihood that any given guideline was produced so as to reduce the influence of conflicts of interest on it is low. Even organizations that ostensibly put professional values and patients first in their efforts to develop guidelines seem to often be financially beholden to companies that want to sell drugs and devices. Physicians and patients ought to be concerned that most new clinical practice guidelines may be as much about marketing commercial products as improving medical practice or patients' outcomes.
The current US presidential race has made it evident that we have a lot of disgruntled citizens, many of whom believe our system is rigged to favor the "establishment." I suggest that the more we know about clinical practice guidelines, the more it appears that the health care system is rigged to favor certain parts of the "establishment," the big corporations that market drugs and devices, and their paid part-time hands within medical societies and patient advocacy groups who have turned these ostensibly idealistic, do gooder organizations into part-time marketing machines.
The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system. True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.
Musical Interlude
To dispel the darkness a bit, Paul Simon, "Still Crazy After All These Years," 1992 acoustic version:
References
1. Campsall P et al. Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study. PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002029 Link here.
2. Bastien H. Nondisclosure of financial interest in clinical practice guideline development: an intractable problem? PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002030 Link here.
North Carolina Family Plans Already Cost More Than $10,000 a Year With Rates Going Up By Double Digits for 2017
With one state after another announcing big 2017 Obamacare rate increases the latest refrain from Obamacare supporters is that with maybe one or two more years of rate increases everything will be fine.
What is euphemistically referred to as an "IT system error" is, in reality, the mass delivery of a grossly defective medical device adversely affecting hundreds of thousands of patients. I'm surprised not to see that other kindly euphemism, "glitch" (http://hcrenewal.blogspot.com/search/label/glitch):
Hundreds of thousands of patients have potentially been given an incorrect cardiovascular risk estimation after a major IT system error, Pulse can reveal.
The MHRA has told GPs they will have to contact patients who have been affected by a bug in the SystmOne clinical IT software since 2009.
The regulator says that means that ‘a limited number’ of patients may be affected, and the risk to patients is ‘low’.
At best, it's good that only a "limited number" of patients were "affected." I guess they feel they can justify a "limited number" of patient harms for the glory of a medical Cybernetic Utopia.
At worst, how do "the regulators" know exactly who was affected? Answer: they don't and this is boilerplate BS meant to CYA.
But Pulse has learnt that the 2,500 practices using SystmOne are having lists sent to them of around 20 patients per partner who may need to be taken off statins, or be put on them, after their risk is recalculated.
Statins also carry warnings that memory loss, mental confusion, high blood sugar, and type 2 diabetes are possible side effects. It's important to remember that statins may also interact with other medications you take.
Not to mention the risks of not being on a statin if you truly need one.
And this number could increase if a practice provides NHS Health Checks routinely. In addition, the lists being sent to practices only go back to October 2015, but practices will be sent further lists potentially dating back to 2009 over the next few weeks.
Wait! The "regulators" said that ‘a limited number’ of patients may be affected. They are clairvoyant, I would imagine. Maybe one of them is Harry Potter?
The "regulators", who have the same powers as the man-wizard above, know through clairvoyance that only a limited number of people were affected, and risk to them low.
A statement from MHRA to Pulse said: 'An investigation has been launched into a digital calculator used by some GPs to assess the potential risk of cardiovascular disease (CVD) in patients.
'We are working closely with the company responsible for the software to establish the problem and address any issues identified.
The problem is incompetence and negligence. One wonders what testing was performed before this was unleashed on the public in the UK.
TPP told Pulse they were working to address the ‘Clinical Safety Incident’ and that the QRISK calculator was provided as an advisory tool to support decision making. They added they were working to ensure the issues were addressed and GPs are informed of affected patients ‘as soon as possible’.
‘Clinical Safety Incident’ - what a wonderful euphemism for "healthcare IT debacle."
Deputy chair of the GPC’s IT subcommittee Dr Grant Ingrams told Pulse it would be ’loads of work’ to sort out.
He said: ‘It affects everyone who has had a QRISK, and SystmOne are sending out messages to say “look at these patients”. But then you have to see if the change is significant, and whether you would have made a different decision at the time, or put them on a different treatment’
It will probably be more work than if such a system had never been constructed.
Dr Ingrams said: ‘There’s potential harm both ways…What happens when a patient who had been of a high risk and this hadn’t been identified and they’ve now had a stroke or heart attack? ‘Similarly if someone had a low risk and they’ve been put on a statin and had a side-effect who’s responsible? That’s the clinical risk.’
Answer: the company that produced this grossly defective software, and those "regulators" who allowed it on the market without independent and thorough testing, are responsible.
Dr William Beeby deputy chair of the GPC’s clinical and prescribing subcommittee, said the bug ‘certainly had the potential to impact on patient confidence’ and this could create even more work ... ‘It’s the tool we’ve been told to use. So if the tool is inaccurate, then you start to lose confidence and the doctors will then lose confidence as well.’
However, it seems, hyper-enthusiast overconfidence in health IT, including that of the "regulators", would not be injured even if bad health IT caused more casualties than the bombings and V2 attacks suffered by the UK in WW2.
After the health IT debacles involving billions of wasted pounds in the UK, perhaps the UK's "regulators" need to look upon health IT as fondly as this piece of technological wizardry.
A TPP spokesperson told Pulse: 'TPP is dealing with the Clinical Safety Incident involving the QRISK2 Calculator in SystmOne. The tool is intended to support GPs in assessing patients at risk of developing cardiovascular disease and in developing treatment plans. The QRISK2 Calculator is presented within SystmOne as an advisory tool.
"Advisory tool"? That the doctors can safely ignore? Hogwash.
’We are actively working to ensure the issues identified are addressed and to ensure that clinicians are informed of any patients that may have been affected as soon as possible.’
To hell with doctors and nurses and their concerns about horrible health IT.
That seems the international standard in 2016 regarding their concerns. There's just too much money to be made in this business to worry about such piddling annoyances as maimed and dead patients.
Doctors, after all, don't know anything about computers, and cybernetic medical experiments on unconsenting human subjects are just good fun.
Nanaimo doctors say electronic health record system unsafe, should be shut down
By Cindy E. Harnett Victoria Times Colonist May 27, 2016
Implementation of a $174-million Vancouver Island-wide electronic health record system in Nanaimo Regional General Hospital — set to expand to Victoria by late 2017 — is a huge failure, say senior physicians.
Who cares what they say? They're just doctors, so sayeth the imperial hospital executives..
After a year of testing, the new paperless iHealth system rolled out in Nanaimo on March 19. Island Health heralds the system as the first in the province to connect all acute-care and diagnostic services through one electronic patient medical record, the first fully integrated electronic chart in the province.
But he's a doctor too, so what does he know, sayeth the hospital executives.
But nine weeks after startup, physicians in the Nanaimo hospital’s intensive-care and emergency departments reverted to pen and paper this week “out of concern for patient safety.”
Doctors said the system is flawed — generating wrong dosages for the most dangerous of drugs, diminishing time for patient consultation, and losing critical information and orders.
“The whole thing is a mess,” said a senior physician. “What you type into the computer is not what comes out the other end.
“It’s unusable and it’s unsafe. I’m surprised they haven’t pulled it. I’ve never seen errors of the kind we are now seeing.”
Doctors are so concerned, they want Island Health to suspend the implementation.
“Take it away and fix it and test it before you bring it back — stop testing it on our people,” said one doctor. “Why wasn’t this introduced in Victoria first? If they went live in Victoria first, they would have a riot.”
(Is there anything unclear there, I ask?)
SHUT UP DOCTORS. IT''S PERFECTLY SAFE, sayeth the administration.
The doctors, who fear reprisals, spoke to the Times Colonist on condition of anonymity.
If doctors did not fear reprisals I'd have a full time job writing on EHR debacles. I could almost have one now.
The $174-million system started with a 10-year, $50-million deal for software and professional services signed in 2013 with Cerner Corporation, a health information technology company headquartered in Kansas City. Thus far, the company has been paid close to $12 million. The remaining $124 million is to be spent by Island Health for hardware, training and operating the system.
The system is being used in Nanaimo’s hospital, Dufferin Place residential care centre (also in Nanaimo), and Oceanside Health Centre in Parksville.
Since March 19, mobile touch-screen computer console carts have been rolling around hospital hallways. Voice-recognition dictation software immediately transcribes a doctor’s verbal notes into a patient’s electronic record, and scanners track each bar-coded patient bracelet around the hospital. But doctors complain the new technology is slow, overly complicated and inefficient.
Today's clinical IT is needlessly and blindingly complex. But hospital executives are, in my increasing view, too ignorant to recognize the necessity of simplicity in critical functions such as clinical medicine. Their jobs are child's play in comparison. (I should know; I once was a health IT executive after having practiced medicine for a number of years.)
“The iHealth computer interface for ordering medications and tests is so poorly designed that not only does it take doctors more than twice as long to enter orders, even with that extra effort, serious errors are occurring on multiple patients every single day,” wrote one physician at the Nanaimo hospital.
In view of current warnings and that which is known, and has been known for many years from the literature about bad health IT, each and every adverse outcome of injury that occurs represents hospital executive gross negligence:
Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary Negligence, which is a mere failure to exercise reasonable care. http://legal-dictionary.thefreedictionary.com/gross+negligence
I leave it to the reader to classify patient deaths.
“Tests are being delayed. Medications are being missed or accidentally discontinued.”
My mother and other patients in whose litigation I have provided informatics expertise were injured and/or died from precisely that type of mistake.
Doctors can’t easily find information entered by nurses, the physician wrote.
There are also complaints about the pharmacy module of Cerner’s integrated system — the only joint build between Island Health and Cerner.
iHealth implementation staff brought in to input orders for physicians this week entered eight drug mistakes on one day and 10 on another, while there were no mistakes in the paper orders, doctors said. “If the experts can’t enter it correctly, what is the average Joe going to do?” one doctor said.
Suffer, and take on all the liability, of course.
Another problem, they said, is patients’ drug orders disappearing from the system.
... But Island Health spokeswoman Antoniette O’Keeffe said the system is safe and doing what it’s intended to do.
To hell with the doctors concerns and with the patients.
“We are not going back to paper,” she said. “We can’t go back to paper. We don’t have the mechanics to go back to paper.”
I'll be generous about the stupidity represented by that statement. What she means is, we've jsut blown tens of millions of dollars on computers. We'd get out asses kicked by the Board if we admitted we blew it and went back to paper.
Island Health acknowledges that documentation for staff doing emergency-department patient intake was a challenge, noting Nanaimo is the busiest emergency department on the Island.
A mere "challenge." How about "was not possible in a 24 hour day?"
Nanaimo has some of the top physicians in the country and “we respect the feedback they are giving us, and so we are listening to them and we are tweaking and modifying the system,” O’Keeffe said.
We respect their feedback. They say it should be shut down, but "the system is safe and doing what it’s intended to do."
Challenges include getting medication orders into the system, getting clinical staff trained, work flow and documentation, O’Keeffe said.
More staff have been added to speed up admissions and others are working around the clock in the intensive-care and emergency departments to input handwritten physician orders into the system, O’Keeffe said.
Cerner is working with Island Health staff, “and they’ll be here until we get this fully implemented,” O’Keeffe said.
Island Health credits the system’s electronic warnings for catching about 400 human-caused medication errors and conflicts at three sites, saying it’s a sign that the system is working. It will produce a warning, for example, if the dosage is too high for a patient’s weight, if the drug is not appropriate for a particular disease or if there’s a drug conflict.
Across the country, thousands of medication mistakes are made daily due to human error, “and this system is designed to catch them,” O’Keeffe said.
Doctors respond that so many irrelevant flags pop up, it creates confusion, while the computer loses or duplicates drug orders.
Ms. O'Keefe and her administration are obviously blissfully unaware of how health IT can cause medication errors en masse impossible with paper, e.g., "Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands", http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html. Of course, many hospital executives are ill-informed, lacking the curiosity of the average scientist or physician.
The system was a decade in the making for Island Health. Twenty-three clinical teams were involved in developing various components and there was user-group testing, modifications and feedback, O’Keeffe said. Training has gone on for the last year, she said. “You can only bring a system so far and then you have to put it in a real environment to test it.”
At best - test it - yes, on unsuspecting human subjects known as patients, doctors and nurses. The ones who are harmed and the ones who die are worthy human sacrifice for the glory of computing, eh, Ms. O'Keefe? At worst - what is wrong with this industry that each and every installation of this technology is an experiment?
Is it that the technology has exceeded the intellectual horsepower of available personnel? In my experience that has seemed to be the case.
By the end of the implementation, it’s expected family doctors will also be able to access patient files started in acute-care settings. Island Health is working on that component now, O’Keeffe said. Once the system is working smoothly in Nanaimo, it will be installed in the north Island and then Victoria hospitals in 12 to 18 months, O’Keeffe said.
It is grim, written by a doctor under a pseudonym (Dr. Winston Smith is the pseudonym for a doctor in Nanaimo - that says much about fear of retaliation):
One health record. Making care delivery easier for health-care providers. Safer health care. These are the claims Island Health has made publicly for its new electronic health-record system iHealth, introduced initially at Nanaimo Regional General Hospital in March and intended to roll out across Vancouver Island in the coming months. These are goals physicians share — many of whom enthusiastically use electronic records in their clinics. Despite “bumps in the road,” Island Health claims the implementation of the system is going well. But these claims are untrue. iHealth does not provide a single health record: It offers no less disjointed and poorly accessible a collection of patient information in differing programs and sites than the previous system. The system is cumbersome, inefficient, not intuitive — and not simply because it is a new system, but because of its very nature. It’s like trying to make a DOS-based computer work like an Apple or Windows-based system: You can perform many of the same functions, but it is slow, takes multiple steps and is inefficient. Even the youngest generation, who have grown up with computers, and those with computing science degrees can’t make it work effectively. The system’s ordering function is faulty and requires multiple separate steps and choices to order a simple medication: A processing issue safety experts know is highly likely to cause error. And the system sometimes makes default changes in medication orders without the knowledge of the ordering physician. Single orders for medications disappear from the record, so that duplicate orders are initiated by unknowing doctors. The consequence of these problems is that hospital-based care delivery is slower, more inefficient, more prone to error. Health-care providers are found interacting with their mobile computer monitors in already overcrowded hallways rather than providing direct patient care. Nurses and doctors have less of a holistic appreciation of their patients and their illnesses because of the disjointed complexity of the electronic record rather than the simple navigability of the previous paper record and charting. And communication with the computer system has supplanted direct discussion between health-care team members: Like trying to manage complex illnesses through text messages. Health-care delivery is slower, so surgical operations are cancelled or delayed and patients leave the emergency department without being assessed; patients are not seen in a timely fashion or at all by specialists; medication errors are regular, so patients are medicated inappropriately or even overdosed; and some of our most experienced and valued health-care providers opt for early retirement or leave rather than continue the frustration and moral distress that this system has generated. And the effect of iHealth is not restricted to the hospital, as some specialists have reduced their outpatient service because of the increased workload iHealth has caused. In short, health care is not easier or better. The quality of care is worse and access is reduced. Improvements can be made and have been, but the system is fundamentally flawed. The impact on work efficiency and quality will never return to previous levels — a fact even the Island Health iHealth “champions” acknowledge. Worse, iHealth is unsafe and dangerous. Medicine strives to be evidence-based, but there’s no evidence electronic record systems improve quality of care, and plenty of evidence they do the opposite — particularly this one. Doctors have expressed their concerns to Island Health. Rather than suspending the system, the health authority’s response has been simply to delay its rollout beyond Nanaimo. It’s OK to let our community suffer while they tinker. Dr. Brendan Carr, the CEO of Island Health, tells us he’ll “do whatever it takes to make this work,” even while continuing to risk worsening quality of care and expending more of our taxpayer dollars — $200 million so far, a fraction of which applied to delivery of health-care services could provide inordinately better health-care outcomes than any electronic record can do. The medical community has finally taken matters into our own hands in the interests of patient safety, quality of care and access. A number of departments are refusing to continue using the system and instead returning to the previous one. Why does Island Health not withdraw this system? In sum, they’ve spent a lot of taxpayers’ dollars on iHealth, a product of Cerner, which has been sued by hospital systems in the United States. And as with many such systems, the objective has not been better patient care, but has been more Orwellian: Improved administrative data and control — no wonder Island Health is loath to give it up. Well, Dr. Carr, the patient should be paramount. I and my family and my community are not expendable. No electronic record system should be introduced that will not explicitly improve health care, patient safety and access. Any deterioration in health care is not an acceptable outcome. Suspend the iHealth experiment. Stop wasting taxpayer dollars. Sue for our money back for having been sold a lemon (as other jurisdictions have done). Spend our tax dollars on services, infrastructure and equipment that will improve health care, not make it worse. Dr. Winston Smith is the pseudonym for a doctor in Nanaimo. - See more at: http://www.timescolonist.com/opinion/op-ed/comment-new-computer-system-a-detriment-to-health-care-1.2264274#sthash.rWwQcJZA.dpuf
... The system is cumbersome, inefficient, not intuitive — and not simply because it is a new system, but because of its very nature. It’s like trying to make a DOS-based computer work like an Apple or Windows-based system: You can perform many of the same functions, but it is slow, takes multiple steps and is inefficient.
Even the youngest generation, who have grown up with computers, and those with computing science degrees can’t make it work effectively.
The system’s ordering function is faulty and requires multiple separate steps and choices to order a simple medication: A processing issue safety experts know is highly likely to cause error.
And the system sometimes makes default changes in medication orders without the knowledge of the ordering physician. Single orders for medications disappear from the record, so that duplicate orders are initiated by unknowing doctors.
Deadly.
The consequence of these problems is that hospital-based care delivery is slower, more inefficient, more prone to error. Health-care providers are found interacting with their mobile computer monitors in already overcrowded hallways rather than providing direct patient care.
This was not what the pioneers intended.
Nurses and doctors have less of a holistic appreciation of their patients and their illnesses because of the disjointed complexity of the electronic record rather than the simple navigability of the previous paper record and charting.
That sums up a major problem with today's health IT well.
The medical community has finally taken matters into our own hands in the interests of patient safety, quality of care and access. A number of departments are refusing to continue using the system and instead returning to the previous one.
This type of revolt, showing who really owns the hospital, needs to become commonplace.
Why does Island Health not withdraw this system? In sum, they’ve spent a lot of taxpayers’ dollars on iHealth, a product of Cerner, which has been sued by hospital systems in the United States.
And as with many such systems, the objective has not been better patient care, but has been more Orwellian: Improved administrative data and control — no wonder Island Health is loath to give it up.
Indeed.
The CEO is himself a physician:
Well, Dr. Carr, the patient should be paramount. I and my family and my community are not expendable. No electronic record system should be introduced that will not explicitly improve health care, patient safety and access.
This anonymous doctor needs to speak to my mother, who I visited yesterday along with my father, on U.S. Memorial Day - at the cemetery after her encounter with bad health IT.
