Cogs in the Money Machine: Money and Trust

Everyone has to make money of course, and there’s not one thing wrong with that.  But, encountering our medical and payment systems, patients now (accurately) perceive that money is the primary object for most of the institutions involved (insurance companies, pharmaceutical companies, hospitals) and for a few of the individuals one encounters (and probably for more than a few of the individuals one does not meet).

Although patients seldom articulate this, they sense what Dr. David Belk accurately states at his interesting website, that prices are deliberately confusing and obscure. It's a scary situation when one cannot know what costs one is incurring.  As Dr. Belk states, this byzantine non-system is designed to benefit someone -- because “[w]hen [it is so difficult to determine costs and prices], you have to ask how much trouble someone has taken to hide it.” (Patients, of course, do not generally understand that prices are as confusing and unknowable to most doctors as to most patients, a point Dr. Belk makes well.) As Dr. Belk notes: “This is a big problem - any cost that is hidden or confusing is easy to inflate.”

That the obscurity is deliberate is underlined by recent developments in Texas. Prompted by patients who had had unpleasant billing surprises, the insurance regulator had put out proposed rules for insurance companies that would require them to disclose on their provider directories whether in-network facilities had in-network anesthesiologists, ER doctors, pathologists and so forth. In-network facilities with ample in-network ancillary-service providers would be labelled “approved,” and those with few or no providers “limited.” As well, insurers would be forced to post a web notice if this situation changed markedly – when there was a 75% or greater decrease in in-network providers available at a facility. This would assist patients to minimize their chances of out-of-network billing.

But recently, Perry’s Texas Insurance Commissioner appointee firmly quashed these provisions before they took effect. Eleanor Kitzman disingenuously claimed that these requirements would “not provide substantial benefit to consumers and [might] lead to increased premiums,” saying it would confuse consumers. “I just don’t believe that consumers, the average consumer, is really going to be able to use that information in a meaningful way.”

A personal experience of deliberate obscurity makes this particularly interesting to me. Last fall, I had cataract surgery at Bailey Square, a day surgery center in Austin, Texas. Bailey Square got all my insurance details beforehand; then they informed me to the penny of the exact amount to bring in during a detailed phone conversation several days before surgery.  I brought the check with me the day of surgery, and was then surprised to be asked to sign a form stating that anesthesiology charges might be out-of-network and they were my responsibility regardless. That was of course too late for me to do any checking. In the event, the anesthesiologists were on my insurance, so I owed only $25 rather than their full $500 charge – but I am sure than not every patient is so fortunate. However, I thought it was sleazy that, when it concerned my money, they chose to spring the news on me too late for me to do anything, but when it concerned their money, they made sure they provided full details well in advance. I wrote the head of the facility complaining about this. I suggested they disclose this in the advance phone conversation when a patient is told how much money they will owe. Unsurprisingly, he never responded.

Another Austin example of charging obscurity is when patients who hoped to avoid ER charges by going to an “urgent care center” found that some urgent care centers are charging as hospital ERs. (Some of  the yelp  reviews indicate that some of the generally good doctors and nurses at these centers are embarrassed and apologetic about this.)

But this post is not a plea for financial transparency. I want rather to reflect on how it affects patient trust when people feel like cogs in a money machine (I could write another post but won’t about the effects on physician morale of constantly playing insurance games in this darkness, after all they too are cogs in other people’s money machines). When one needs to be constantly suspicious about the bizarre charge system, this also affects patient attitudes in other ways and creates a general suspicion, which sometimes is warranted and sometimes is not. Either way, it is corrosive to good relationships and good care.

To see the impact, read this very harsh post about colonscopy: A Tough Love Colonoscopy Dream. The author writes:

Q. Who can perform a colonoscopy?

A. Watch out. Studies have shown that the experience and quality of the scope user (we now use the term endoscopist more frequently) is essential. You want a GI specialist who has performed hundreds or thousands of these. Of course we used to say that you always wanted a physician for all your medical care, not one of those Nurse Practitioners or Nurse Anesthetists, until we were able to employ Physician Assistants in our practices to increase patient care, and coincidentally, our income. Money is not a factor in our decisions. But make no mistake about it. A Physicians Assistant is no doctor. . . .

Q. How come I don’t know any of this?

A. Because we do not want you to. It could ruin business, but we do not make decisions based upon financial gain. And of course it would limit the help we can give our beloved patients. And then there are the Porsche payments. . . .

He concludes:

It is too bad for you that you are getting into the [medical] system. But you have to get used to it, as you are not getting any younger. And no one can get by without medical care. The healthcare industry controls that at every level. For profit. And you cannot change it, so you had better learn to navigate it if you want to avoid the most horrible outcomes.

Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the 2nd International Summit on the Future of Health Privacy where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health IT damages the physician-patient relationship, the bedrock of good medicine, in one case via an inexcusable health IT defect.

The defect nearly cost a woman her good reputation - and her child - by "transforming" coffee drinking into solvent sniffing.

The video is here:  http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx

Dr. Monteith on how bad health IT damages trust.  See video at this link starting at 4:40.

Dr. Monteith starts at 4:40 when he is asked

"Do you feel HIT affects the willingness of patients to share sensitive information with providers?"

His answer is a definite "yes", and the video should be seen to understand his reasons, the largest one being the trust that is injured by this technology as currently (mal)implemented, failing to maintain privacy, data integrity, affecting doctor-patient interaction (e.g., due to poor usability), etc.

His two examples where HIT has injured trust, resulting in decreased willingness of patients to share sensitive information:

• A patient feared compromised privacy regarding psychiatric information (a fear that was certainly well-justified in view of ABC's recent expose of health IT breaches as I wrote about at my Sep. 14, 2012 post "A Reason to Refuse Use of EHR's in Your Health Care, and Demand Paper.")

• An error in EHR-generated record affecting a child custody battle, with a husband alleging unfitness of the mother due to substance abuse.  The EHR incorrectly showed a damaging diagnosis due to both a data mapping flaw (lumping multiple diagnoses under the same code) and a user interface flaw (permitting all of the diagnoses lumped under that code to not be seen, only the worst one) that transformed caffeine (i.e., coffee) overuse to "inhalant abuse."  

Stunningly, Dr. Monteith reported the error was not remediated even after several years.

As seen by the voluntary reports submitted by one of many HIT sellers (link), the only one that seems to do so, and some involuntary ones such as at this link, these issues are just the "tip of the iceberg." That exact phrase was uttered by a senior FDA official himself, reflecting known severe impediments to information diffusion on harms, as I reported at this link.

Yet the government (e.g., HHS's Office of the National Coordinator for Health Information Technology, ONC) and IT industry push this technology like candy, emphasizing largely unproven benefits and completely ignoring downsides such as damaged trust, damaged reputations that could have cost a woman custody of her child, and damaged bodies.

A video of an attorney personally affected by these issues is at this link:   http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx

-- SS

Twilight of the Anechoic Effect? - New England Journal of Medicine Article Discusses Previously Taboo Topic of Bad Corporate Health Care Leadership

We have often complained of the anechoic effect, that the issues we discuss on Health Care Renewal often do not seem to be considered topics of polite conversation.  Any discussion that might question the brilliance, integrity, dedication, or selflessness of the leaders of health care organizations seems particularly taboo. 

So a major aim of this blog has been to discuss the numerous publicly available examples of leadership that is ill-informed, uncaring about or hostile to the values of health care professionals, incompetent, self-interested, conflicted, or outright corrupt, and of governance that lacks accountability, transparency, integrity, honesty, or ethics.  We have postulated that such problems with leadership and governance are not only causes, but the major causes of the increasing dysfunction of our health care system.  That discussing these issues is simply not done in many contexts, including academic health care, medical and health care journals, and health policy fora has only accelerated health care dysfunction.

The New England Journal on Punishing Health Care Fraud

Therefore, I note with some surprise that the New England Journal of Medicine just published an article (online first) that implicitly challenged the leadership of some large health care organizations. [Outterson K. Punishing health care fraud - is the GSK settlement sufficient.  N Engl J Med 2012; 367: 1082 - 1085.  Link here.]

The article summarized the record settling legal settlement agreed to by GlaxoSmithKline (see this post).  It noted that the company pleaded guilty to three criminal charges.  It then noted that while this was the largest recent legal settlement by a pharmaceutical company, "it would be a mistake to assume that GSK was an outlier in the global pharmaceutical and medical-device industries. Indeed, many of the major companies have settled with the Department of Justice in recent years."  It included a table of the largest pharmaceutical company settlements with the US government from 2009 to now.

Based on this background, the article dared to question whether such settlements deter bad behavior:

But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies' revenue. Companies might well view such fines as merely a cost of doing business — a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms' past misdeeds.

Even more daring was its challenge to top executives of pharmaceutical corporations,

One partial solution would be to impose penalties on corporate executives rather than just the company as a whole. Boston whistleblower attorney Robert M. Thomas, Jr., embraces this approach: 'GSK is a recidivist. How can a company commit a $1 billion crime and no individual is held responsible?'

A Taboo Broken

Having blogged on Health Care Renewal for nearly eight years, I recall very few, if any instances in which leaders of health care organizations were described as deserving punishment, or perhaps even guilty of crimes within large circulation medical journals, and within the New England Journal of Medicine, the most prominent US journal in particular. While discussion of misbehavior within health care organizations has slowly been seeping into the medical and health care literature, delicate phrasing has often been employed that leaves unclear whether top executives have any accountability for this behavior. (For example, while the Lancet editorial on the GSK settlement condemned "GSK's fraud," accused GSK of "actively encouraging off-label prescription," and asserted that "GSK and other drug companies have come adrift from standards of the societies they seek to serve," it never said anything about GSK's leaders or whether they in paticular had anything to do with the company's bad behavior. [Anon. Moral decaly at GSK reaps record US$# billion fine. Lancet 2010; 380: 2. Link here.])

So it is a big step for the NEJM to publish an article that suggests corporate executives might deserve penalties. I hope that this publication might lead to a bit of discussion of these issues within the larger medical and health care communities, the vast majority of whom have likely never heard of this blog and may have never seen anything other than an occasional news article in local media questioning the leadership of large health care organizations.

Things are Even Worse

Unfortunately, I need to end with the observation that the problems are even worse than what the NEJM article implies. Legal settlements of allegations of bad behavior by large health care organizations are much more numerous than those mentioned in this article (look here for examples).

Many of the largest and most prestigious organizations actually have histories of multiple settlements, guilty pleas, and related legal and governmental findings. For example, look here for Pfizer's record, here for Johnson and Johnson's record, here for Abbott's record, and here for Wellpoint's record. Pfizer was even found by a jury to be a racketeering influenced and corrupt organization (RICO)(see post here).

Despite these records of recidivism, no leaders of these companies have paid any individual penalties, and none of these organizations have had any restructuring or leadership changes imposed. This is even more disturbing when this kid-glove treatment of misbehavior by big health care organizations is contrasted with the severe penalties imposed on individuals or leaders of small companies found guilty of health care fraud (look here).

You Heard It Here First

However, in 2003 we first published documentation of individual physicians' concerns that ill-informed, incompetent, self-interested, or even corrupt leadership was threatening their core values [Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here.] Furthermore, since 2008 we have been stating that corporate fines do not deter bad behavior.

It is not that law enforcement does not have the power to seek penalties on individuals. As we noted here, a Supreme Court case from 1943 empowered the government to seek penalties against responsible corporate officers (the "responsible corporate officer doctrine") who were in a position to stop a fraud that resulted in a guilty plea or conviction, particularly for the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act.  (This was exactly the situation dealt with by the GSK settlement.)  Despite a threat made in 2010 by the chief counsel of the Inspector General's office of the US Department of Health and Human Services to use such legal authority to "get high level executives out of companies," nothing of the sort has happened.

So now that it is no longer taboo to question the pretensions of some leaders of health care organizations to near divine purity, let me state as I did in 2008,

As long as health care leaders can shrug off the consequences of unethical behavior merely as acceptable costs of doing business, absent any serious attempts to get health care organizations to enforce internal codes of ethical behavior or to avoid hiring ethically challenged leaders, the procession will likely continue. The effects will be continually rising costs, declining quality, shrinking access, and rising numbers of demoralized health professionals.

As I wrote in 2009,

Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

A Good Reason to Refuse Use of Today's EHR's in Your Health Care, and Demand Paper

I've written before that health IT, including the technology and the social infrastructure in which it resides, is not ready for widespread diffusion.  Its widespread dissemination (on largely economic grounds) at this point in its development is premature, and is destructive.

So much, in fact, that I am considering demanding that any physician I see or hospital I visit use paper records, not any EHR they have available.

Think that extreme?  In the real world as it exists today, perhaps the notion that one should freely spill one's deepest confidences into an insecure EHR system is the extreme view.

The reason (aside from the risk today's clinical information technology presents):  yet another addition to my series of posts on health IT privacy breaches at this query link, this time from ABC News:

Your Medical Records May Not Be Private: ABC News Investigation

BY JIM AVILA (@JimAvilaABC) AND SERENA MARSHALL (@SerenaMarsh)

Sept. 13, 2012

Psychiatric Therapy Notes Get Shared Within One Health Care System; and Other Info Spreads on a Black Market

You walk into the doctor's office. They lead you to a private room and shut the door. The nurse enters writes on a chart (or maybe an iPad) and shuts the door. A doctor enters and shuts the door.

It all screams of privacy -- privacy you expect.

But what if you were to find out those medical records containing your private history, family history and medication history weren't so private after all?

Considering electronic breaches in other sectors, and the fact that hospitals' core competencies do not include computing or computer security, why would anyone expect privacy?

Julie, a lawyer from Boston, discovered that her sensitive health information was available to anyone who worked at the hospital.  (See video of Julie at this link).

For an attorney who might be involved in nasty litigation, that is not a career-enhancing prospect.

"My expectation was that my records were going to be private, especially my therapy records," Julie said. "And if another doctor wanted to see my records, they'd ask me and then I'd give my authorization for them to view my records if they needed to see them."

In an ideal world not pervaded by inappropriate leadership of health IT and incompetence, perhaps.

Julie, who requested her last name not be used, was diagnosed with in her late teens and began seeing a psychiatrist in 2002 after speaking with her primary care physician.

She, like millions of Americans, thought her conversations with her psychiatrist were confidential.

"I thought I had protection under HIPAA (the Health Insurance Portability and Accountability Act) for my psychotherapy notes to be private and I thought only my psychiatrist could see those," the 42-year-old said, adding that she noticed over the years her physician started entering them electronically.

A law is only as good as the technology and people behind it, and technology and the people may not be so good:

According to the HHS Health Information Privacy Tool, there were at least 78 breaches so far this year affecting 500 or more individuals, many affecting thousands, some tens of thousands.

Known to those in the health IT world as the "Wall of Shame," the HHS site lists more than 21 million individuals who have been victims to date.

The Privacy Rights Clearinghouse found more than 130 breaches so far in 2012 -- breaches affecting any number of individuals.

Try that with paper...how many 18-wheel trucks would it take to haul 21 million charts?

What she didn't realize was that her physician's notes could be accessed by doctors and other health-care providers who worked in the same health-care system (6,000 doctors and nine affiliated hospitals) to have access -- information she learned after going to see an on-call physician for a stomach issue and realizing he knew about intimate relationship information only disclosed to her psychiatrist.

Concerned, she requested a copy of her medical records from the health care system.

Within those records she saw every note, every meeting, every conversation she had with her psychiatrist.

"It was pretty traumatic because I felt that, you know, this man read without -- against my wishes -- without my consent," Julie said. "He read private information that I disclosed to a therapist that I didn't even tell my best friends about."

There are supposed to be multiple levels of access security in EHR's, but that has to 1) work properly out of the box, 2) be implemented properly, and 3) be enforced.  That's three very large assumptions...

And while most hospitals have rules about who may access medical records, compliance for the most part is not strictly regulated.

Indeed.

In fact, an ABC News investigation found that often medical information is so unprotected, millions of records can be bought online. Because so many people have access, the entire system is vulnerable to theft, experts told ABC News.

These are an on-their-face reasons to refuse entry of your data in EMR systems.

To see exactly how easy it was to find medical records online, ABC News enlisted the help of IT specialist Greg Porter, a consultant with Allegheny Digital.

"This isn't very sophisticated," Porter said. "If you can use a Web browser and you can search to www.google.com, you can begin to try and obtain some of this information."

With two clicks of a mouse, Porter found somebody willing to sell a data dump of diabetic patients with information including their names, birth dates and who their insurance provider was, among other details. Another seller offered 100,000 records of customers who purchased health insurance in the last three to 12 months.

"Typically, what we find are things like first name, last name, address, medical condition, whether they were a smoker, diabetic patient, perhaps even as intensive as, or invasive as whether they are HIV-positive or not," Porter said. "Some of the most intimate information about all of us potentially could be revealed if appropriate safeguards aren't put in place.

Putting appropriate "safeguards" into place hurts healthcare organizations' bottom lines.

Security professionals are seeing an increase in theft via the "insider threat," Porter said.

"It's a depressed global economy," Porter added. Thieves might approach medical staff and offer upward of $500 per week for providing 20 to 25 insurance claim forms, medical records or health financing records, Porter said. Those documents fall under HIPAA security rules and are considered protected health information.

Could never happen, right?

In June, a hospital medical technician at Howard University pleaded guilty to selling patient information, including names, birth dates and Medicare numbers, for $500 to $800 per transaction for more than a year.

In August, a hospital employee at Florida Hospital Celebration was arrested for accessing more than 700,000 patient records in two years.

According to the FBI, Dale Munroe accessed car accident victims' date and sold it to someone who passed it on to chiropractors and attorneys.

And this week, the University of Miami Health System said that two workers had "inappropriately" accessed patient data and "may have sold the information to a third party."

On the black market, "health information is far more valuable than Social Security numbers," said Dr. Deborah Peel, founder and chairwoman of Patient Privacy Rights.

I stand corrected.

ABC News' searches found one seller offering database dumps for $14 to $25 per person. After a quick email inquiry into the sale of records, ABC News was sent, unsolicited, 40 individuals' private health information, including their names, addresses and body mass index.

Another inquiry yielded an offer of more than 100 records that, if purchased, would have included everything from Social Security numbers to whether someone suffered from anxiety or hypertension, or even their HIV status.

ABC News contacted patients from one of the lists to see if they knew their information was being sold over the Internet and if they had consented.

One victim named Rafael said he had not "recalled" giving anyone permission to sell his information.

"I'm appalled, I'm disgusted and I'm very much concerned," Rafael said. "Who's giving out my personal information like that? I thought there were security and safeguards for these things. I thought … your medical records are confidential."

So, in addition to the risks to good care posed by today's EHRs, now one has to be concerned about risks to one's privacy, damage to one's career, and to one's financial health as well.

... [Privacy advocate Dr. Deborah] Peel believes ways to fix the privacy vulnerabilities are available. "Technologies exist today to allow you to selectively share parts of your record that are relevant on a need-to-know basis with your other physicians and no one else, but we don't have those technologies in wide use," she said.

Not in the short term, unfortunately.

For Julie, privacy is a battle she continues to fight.

"I asked … please restrict the records and of course they said 'No,'" she said.

Great.  How reassuring.

"Let me also assure you that our physicians and other staff access information on a strictly 'need to know' basis and as such, we do not restrict access to clinical information from any department or physician," the hospital told her. "I take your concerns very seriously and understand your need for privacy with your psychiatric records. Sometimes it can be a challenge to balance access to records for patient care purposes with the need for privacy."

Bullsh*t, I say, having led EMR implementations at large hospitals where these exact issues were considered.

Since discovering her records were available to the whole health system, Julie has stopped seeking care out of concerns for her privacy.

That. of course, destroys the whole purpose of electronic records to "improve access" to "accurate medical information."

... In sharing her story, Julie wanted to come forward for those who couldn't.

"The difference in this situation is I actually chose to come here and I actually chose what I'm gonna say and what I'm not gonna say; but when my medical information is available to everybody, I don't have that decision," she said. "Somebody else is making that decision for me and that really makes me feel violated. So that's why I'm here: Because I think it's a really big problem and I wanted to do something about it. "

The people who in essence are "making that decision for me" are technologists, or technology hyper-enthusiasts, who ignore technology's downsides and ethical considerations.  I defined that defective character type at this post.

The systemic technological and attitudinal problems (further) exposed by this ABC investigation cannot reasonably be expected to be fixed, and probably cannot be fixed, in a short time frame.

Thus, I suggest patients who do not desire to be guinea pigs on health information security, privacy and confidentiality consider refusing use of EHR's to record and diffuse their confidential medical information. A person should not be coerced to risk their privacy and financial security while the health IT industry "gets its act together."

On a pragmatic basis alone in 2012, the risk-to-benefit ratio may simply be too high.  For instance, what are the odds that you'll be found unconscious and without contact information in some distant land, vs. privacy breach or ID theft from an EHR?

Further, there is no legal requirement that electronic records be used for rendering of medical care.  There is also no legal requirement that live patients consent to be used as test subjects for hospitals and software companies in refining their IT systems ("beta testing") to make them secure.

If a physician or hospital refuses to honor the request, and/or refuses to provide care, litigation should be pursued.

-- SS

Lake County Health Department: The extremes to which faith-based informatics beliefs can drive healthcare facilities - Depression era soup lines at the clinic?

Here is a story exemplifying the extremes to which faith-based informatics beliefs can drive healthcare facilities, to the benefit of IT companies and at the expense of patients.  This is occurring a bit north of the Chicago area:

County Health Department clinics moving to electronic records

By Judy Masterson

Last Modified: Sep 11, 2012 02:43AM

People who rely on Lake County Health Department clinics for their health care have found cuts in service during walk-in hours as the department began implementing a new electronic medical record.

 That, as is explained further in the story, is an understatement.

The massive shift to electronic storage of medical data by the department has been underway for about two years, at a cost through April 2012 of $3.8 million, according to department spokeswoman Leslie Piotrowski.

During the first phase, appointment-taking, laboratory, financial and demographic information and billing were transferred from paper records to electronic storage. Under the newest phase of the project, physicians and staff are being trained to use new computer software to electronically gather health histories and record information on tests, treatments and prescriptions.

Are they using the software to record health histories, or to gather them?  There is a difference, and I believe this passage exemplifies that these "EHRs" are no longer innocuous filing systems, but are interfering in and regulating the information gathering process from patients itself (i.e., the physician-patient relationship) itself.  More on that issue below.

Denise Koppit, Health Department associate director of primary care services, acknowledged the training has temporarily cut by half the number of walk-in patients seen at the department’s clinics in Waukegan, Zion, North Chicago, Highland Park and Round Lake Beach.

Cut by 50%?  That is remarkable.  That an electronic record system could be so hard to learn and use that patient count has to be halved is stunning - and outrageous.

It suggests a fiasco in the making in terms of care quality when the clinicians are asked (and probably forced) to get back to more traditional volumes.

Similar situations are noted here:  

"Avatar fails - No, not the Cameron movie, but yet another lousy EMR system implemented by amateurs." http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html

and here:

"Contra Costa's $45 million computer health care system endangering lives, nurses say." http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html

“We’re learning new systems which totally change the way we gather information about patients,” Koppit said, noting “it was a little bumpy” the first day, Sept. 5, but Sept. 6 “it was a little better.”

"Totally change the way we gather information about patients?"  (As opposed to "the way we record information?")

This is concerning to me, as it suggests interference (ill-conceived and deleterious interference is probably more accurate) in medical processes by technology.  To my knowledge, there's been no revolution in clinician history taking and performance of physical exams.  The state government needs to examine exactly what is being referred to.

Also - add "a little bumpy" to the list of banal excuses for toxic software such as - it's a rare event, it's just a 'glitch',  it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, etc.

I'm actually surprised not to see the usual refrain in this article, that "patient care was not compromised."

... “We want to improve quality of care and increase efficiency so patients don’t go through multiple tests and so everyone can see medications,” Koppit said. “This will allow ready access to patient information. Patients will receive a printout of their diagnoses, medications and lab work.”

As described in other posts (query link here), these are "faith-based informatics beliefs" (i.e., enthusiasm and technology-deterministic statements of fait accompli not driven by robust evidence, especially considering the state of health IT in 2012).

Patients who transfer to different providers, will receive their medical history and information in a paper file or on a flash drive.

Paper file?

The reductions in number of walk-in patients accepted hit the Zion clinic especially hard. One user, who contacted the Lake County News-Sun, said patients waiting outside the clinic “on any given day” look like “a Depression-era soup line” that snakes around the corner of 27th Street.

Koppit said that the Zion clinic, which also serves patients from Winthrop Harbor, Beach Park and Wadsworth, relies on just two physicians who typically treat between 12 and 15 walk-ins per day.

Health IT project managers whose plans caused “a Depression-era soup line” of sick patients should be sanctioned, in my opinion. 

When an EMR implementation causes "Depression-era soup lines" at the clinic, one can reasonably conclude project mismanagement is occurring.

This is entirely unnecessary, and endangers patients dependent on the care provided in these clinics.  This project as structured, in fact, violates patient's rights in my opinion.

She admitted that regular appointments can take two months to schedule. “If somebody comes in very sick, we’re trying to get them squeezed in,” she said.

We're "trying to get them squeezed in"?  And, if they are harmed or die because they can't be "squeezed in", or because the clinicians are up to their necks in cybernetic frenzy, who's liable?

I suggest the implementation leadership team should, in that case, find themselves as defendants.

-- SS

How Big Health Care Charities Rely on Lying Telemarketers

A modern day Diogenes searching for an honest organization in health care would have a very hard time.  Close to the "you can't make this stuff up" category is a new investigative report from Bloomberg on deceptive - to use a polite word - practices at some of the US' biggest health care charities.

Using Commercial Telemarketing Firms that Keep Nearly All Money Raised

The report showed how major US health care charities use privately held for-profit telemarketing firm InfoCision Management Corp to raise money, but most of the money raised went back to InfoCision.  The opening example was of a particular telemarketing call:

A woman named Robin said she was representing the American Diabetes Association.

Robin didn’t ask for money. She asked Patterson to stamp and mail pre-printed fundraising letters to 15 neighbors. Both of Patterson’s parents and one grandmother had been diabetic, so she agreed to do it, Bloomberg Markets magazine reports in its October issue.

'I thought since it does run in the family, it wouldn’t hurt for me to help,' says Patterson, 64, a retired elementary school teacher. She guessed, based on what she knew about charity fundraising, that about 70 to 80 percent of the money she brought in would be used for diabetes research.

The truth was almost the exact opposite. The vast majority of funds Patterson, her neighbors and people like them throughout the country would raise -- almost 80 percent -- would never be made available to the Diabetes Association. Instead, that money collected from letters sent to neighbors would go to the company that employed Robin and an army of other paid telephone solicitors: InfoCision Management Corp.

Just 22 percent of the funds the association raised in 2011 from the nationwide neighbor-to-neighbor program went to the charity, according to a report on its national fundraising that InfoCision filed with North Carolina regulators.

So while some American health care charities boast that most of the money they receive goes to programming, not management or fund raising, in this case, the opposite was true.

Many of the Biggest US Health Care Charities Were Involved

As the article stated,

Many of the biggest-name charities in the U.S. have signed similarly one-sided contracts with telemarketers during the past decade. The American Cancer Society, the largest health charity in the U.S., enlisted InfoCision from 1999 to 2011 to raise money.

Also,

In the past decade, many of the nation’s biggest health charities have hired InfoCision, including the American Heart Association, American Lung Association, American Society for the Prevention of Cruelty to Animals, March of Dimes Foundation and National Multiple Sclerosis Society.

Note that the Bloomberg article was focused on InfoCision. I suspect that if one were able to look at arrangements with similar telemarketing firms made by all US health care charities, the results might be even more extreme.

The Fund Raisers and the Charities Lied

The article contained instances in which the telephone callers lied about who they were or about where the money they were trying to collect would go.

First, regarding who the callers were:

The ruse begins with the name that flashes on your caller ID when a telemarketer is phoning on behalf of a charity. It’s the charity’s name that often shows up, not that of the telemarketing firm.

The misrepresentation can continue on the call itself. Solicitors in recordings obtained by the Ohio Attorney General’s Office sometimes identify themselves to potential donors as 'volunteers.' They’re not; they’re paid employees of InfoCision.

Second, regarding where the money would go:

The bigger lie telemarketers tell is what they say about how much money will go to the charities they’re working for.

According to documents obtained through an open records request with the Ohio attorney general, the Diabetes Association approved a script for InfoCision telemarketers in 2010 that includes the following line: 'Overall, about 75 percent of every dollar received goes directly to serving people with diabetes and their families, through programs and research.'

Yet that same year, InfoCision’s contract with the association estimated that the charity would keep just 15 percent of the funds the company raised; the rest would go to InfoCision.

This deception appears to be sanctioned by the leaders of the charities for whom InfoCision worked,

[American Diabetes] Association Vice President [Richard] Erb offers no apologies for the script, saying the association runs many fundraising campaigns and, overall, about 75 percent of the money goes to its programs. He acknowledges that the contract with InfoCision estimated that the telemarketer would get to keep 85 percent of the funds it raised.

Erb also says he isn’t happy that volunteers are upset upon learning the truth.

'Obviously, if people feel betrayed or that we’re not being honest with them, it doesn’t make me feel well,' he says.

The American Cancer Society similarly seemed to sanction deceptive fund raising practices.

The Cancer Society, in a Sept. 1, 2009, contract with InfoCision, estimated that the charity would get 44 percent of the amount the company collected in the following fiscal year.

The telemarketer script for the same year approved by the society for InfoCision asks solicitors to say something different: 'Overall, about 70 cents of every dollar received goes to the programs and services that we provide.'

Predictably, an executive for the society dodged responsibility for such lying:

[Greg] Donaldson, the society’s senior vice president, declined to comment on the contradiction between the contract and the script, saying the society doesn’t provide 'proprietary competitive information regarding individual programs.'

The Telemarketing Firm Stonewalls

While the Bloomberg reporters were able to get some health care "charity" executives to respond to the issues, InfoCision was not even slightly forthcoming. The best they could do was get an InfoCision executive to protest the company's importance for charity:

InfoCision Chief of Staff Steve Brubaker says his company is vital to the success of charity fundraising. Many nonprofits have stayed with InfoCision for more than 20 years, proving the firm offers value and integrity, he says.

'We’ve developed that high level of trust by being good stewards of their money and mission,' he says. Campaigns to develop new donors are more expensive than those seeking money from previous supporters, he says. He declined to answer specific questions, saying such information is proprietary to the company or its clients.

He turned down a request for interviews with Taylor and InfoCision executives.

Previously, the company owner had taken on the mantle now familiar in the current US election campaign, "job creator,"

[InfoCision founder Gary] Taylor was an outspoken opponent of efforts by the Federal Trade Commission in 2003 to begin the National Do Not Call Registry, allowing people to block calls from for-profit solicitors. In an interview with Customer Interaction Solutions, a trade journal, he said:

'The most pressing issue, without a doubt, is excessive governmental regulation. It seems that the politicians and regulators are ignoring the significant benefits we provide through job creation, economic growth and the goods and services we cost-effectively market for our clients.'

Keep in mind that the article documented how much of those jobs are minimum wage, and they may involve lying.

Note further that Taylor "got his start raising money for evangelical preachers." The company also " did fundraising for Citizens United, the conservative group best known as the plaintiff in the Supreme Court case that allowed unlimited independent spending by corporations and unions on behalf of political candidates."

Health Care Charities are Really Just "Businesses"

Underlying all this seems to be the transformation of health care from a calling to a business. While US health care charities have reputations as organizations out to do good, one executive, the American Diabetes Soceiety's Mr Erb, admitted that doing good was no longer really the focus,

'But the thing is, we’re a business. There has never been a time or a place where we said, 'Most of this money is coming to us.''

An expert the Bloomberg reporters interviewed said that the fund raising tactics these organizations used meant they were no longer charities. Per Ken Berger, "who runs Glen Rock, New Jersey- based Charity Navigator, the nation’s largest nonprofit watchdog group,"

'These organizations were created to provide public benefit,' he says. 'The fact that the vast majority of money is instead lining the pockets of telemarketers defies the whole reason behind the very creation of these charities.'

The Experts Say It's Fraud

Bloomberg reporters interviewed several experts on philanthropy and law. They were not amused. One suggested that the fund raising tactics described in the article were fraudulent:

Charities should be held accountable for deceptive fundraising done in their name, says James Cox, a professor at the Duke University School of Law in Durham, North Carolina, and co-author of 'Cox and Hazen on Corporations' (Aspen Publishers, 2003).

'If that’s what they do systematically, then they’re obtaining money under false pretenses,' he says. 'I don’t just think it’s incredible. I’d be surprised if it isn’t criminal.'

Another labeled the practices "deceitful."

Bloomberg cited a 2003 US Supreme Court decision:

While telephone solicitors have no obligation to volunteer what the firm’s cut is of each donation, they don’t have a constitutional right to lie, the court ruled in a 2003 Illinois case.

'States may maintain fraud actions when fundraisers make false or misleading representations designed to deceive donors about how their donations will be used,' the court said.

Summary

This horrendous story illustrates how the mission of health care has been undermined by the last 30 years' push to turn health care organizations into businesses at a time managers were indoctrinated that they only thing that matters is short-term revenue (that is, they have become "financialized," look here). Here we see ostensibly charitable organizations that solicit donations from the public supposedly to aid patients and support medical education and research willing to do whatever it takes to raise money, including deception, and what might be fraud. This is just disgusting.

In my humble opinion, patients, health care professionals, and the public should insist that health care non-profit organizations disclose their fund-raising tactics, and abandon any that are dishonest. Law enforcement should investigate to see if prosecutions for fraud or related crimes are warranted. Organizations that refuse to change their ways should lose their tax exempt status.

Meanwhile, I would suggest that everyone should be extremely skeptical of fund raising by major health care charities. In no instance should anyone give money solely based on telephone solicitations.

If we, health care professionals, patients, the public do not take our heads out of the sand and realize how dishonest health care has become, we will have only ourselves to blame when it collapses.

More Hospices Pretending Patients are Terminally Ill

In the US, we have been engaged in an experiment involving handing over an ever increasing proportion of direct patient care to for-profit corporations, and non-profit organizations that act increasingly like for-profit corporations (as opposed to mission oriented non-profit organizations or individual health care professionals).  The results have been particularly striking for the care of one of the most vulnerable patient groups, the chronically ill. 

Over the last months, a number of stories about the hospices enrolling patients who are not terminally ill have accumulated.  Keep in mind that hospices are supposed to provide compassionate palliative care to the terminally ill.  While they are supposed to make such patients as comfortable and free of pain as is possible, they are not supposed to otherwise aggressively treat other medical problems (based on the assumption that such treatment would benefit dying patients.)  However, such treatments could benefit, or even save the life of patients who are not dying.  (See posts here and here.)

Hospice of the Bluegrass

Back in March, there was very brief report on Kentucky.com that the non-profit Hospice of the Bluegrass "agreed to pay the federal government $685,000 for submitting claims to Medicare to receive reimbursements for services it provided patients who did not qualify for Medicare services,..."  Note that the main requirement for Medicare payments for hospice services is that the patients receiving these services have no more than six months of survival expected.

However, then in June a detailed investigative report also on Kentucky.com recounted numerous conflicts of interest affecting that hospice's board,

The non-profit Hospice of the Bluegrass has spent more than $1.82 million since 2005 on business deals with several of its board members and the spouses of its executives.

In particular,

On its tax returns from 2005 to 2010, Hospice reported paying at least:

■ $540,178 for political lobbying and legal representation to the law firm of McBrayer, McGinnis, Leslie & Kirkland. One of the firm's partners and co-owners, Lisa English Hinkle, was a Hospice board member and a former board chairwoman. Hinkle rotated off the board at the end of 2011. She was preceded on the board by another partner in the firm, James Frazier.

■ $837,999 for insurance to the firm of Powell-Walton-Milward, whose managing director, John Milward, is a Hospice board member. His brother Greg Milward, who also works at the insurance firm, previously was on the Hospice board and was board chairman in 2007.

■ $392,042 for printing to Pat Byrne Printing, owned by the husband of Deede Byrne, Hospice's chief clinical officer.

■ $22,506 for heating and air conditioning to Gary Merckle, husband of Carol Ruggles, Hospice's chief financial officer.

■ $28,577 for advertising to the Lexington Herald-Leader while then-editor Marilyn Thompson sat on the board.

The article also noted that the hospice CEO seems very well-paid given the context,

CEO Gretchen Marcum Brown, whose 2010 compensation was $238,650 in base pay, $10,570 in bonus pay and $84,978 in other reportable compensation. The other compensation included Hospice's payment into Brown's deferred-compensation account, from which she can draw in the future.

Hospice also paid for a membership in Brown's name at The Club at Spindletop Hall, which offers swimming, tennis and dining.

Such a pay package may provide incentives to maximize revenue by maximizing enrollment, regardless of whether enrolled patients really should be in hospice.
Hospice Family Care

As reported by the Phoenix Business Journal in May,

Hospice Family Care Inc. has agreed to pay the federal government $3.7 million to settle civil allegations that the Mesa-based company violated the False Claims Act by submitting false bills to Medicare.

Also,

The U.S. Attorney’s Office had alleged that Hospice Family Care submitted claims for payment to Medicare for patients who were either completely or partially ineligible for hospice,...

So this settlement is partly for charges that the hospice enrolled patients who were not terminally ill.

Note that in this particular case, the government made an effort to punish the owners of the company, who found a way to evade such punishment:

However, on the day the U.S. Attorney’s Office announced that settlement, Hospice Family Care’s owners closed on a deal to sell the company.

So,

Neither the company’s attorney, Frederick Petti, nor government officials would disclose the name of the buyer.

“Unfortunately, I can’t provide that information because it’s not in the public domain,” said Assistant U.S. Attorney Bill Solomon.

The company’s co-owners, Nancy Smith and Nancy Turner, deferred all comments to Petti.

'Believe me, if my clients weren’t in the process of selling this company, we would have fought this to the bitter end,' Petti said. 'We would have prevailed. This is a business decision.'

He emphasized that the settlement agreement was not an admission of guilt.

Smith and Turner agreed to be excluded from Medicare and Medicaid and all other federal health care programs for seven years, effective immediately. However, Petti said the company’s new owners will not be affected by that settlement agreement and will be free to accept reimbursement from government payers.

Such maneuvers obviously reduce any deterrent effect of settlements like this on bad behavior, and particularly on the behavior of enrolling patients who are not terminally ill in hospice.
Harden Healthcare

Then in June the Wichita (Kansas) Eagle reported,

A Kansas hospice care provider and its Texas-based parent company will pay $6.1 million to resolve allegations that they submitted false claims to the federal Medicare program. The case arose from a whistleblower lawsuit filed by a nurse more than six years ago, the U.S. Justice Department said Thursday.

Justice officials said in a news release that they hope the settlement with Wichita-based Hospice Care of Kansas LLC and Fort Worth-based Voyager HospiceCare Inc. will serve as a warning to other hospice providers.

Prosecutors alleged the companies submitted false claims to the federal health care program for the elderly and disabled between 2004 and 2008 for patients who weren’t expected to die in less than six months, a requirement for the benefits in question.

Note that this report makes very explicit the allegation that the hospice was enrolling patients who were not terminally ill. Further note that while the beginning of the report makes it appear that the company that owns the hospice is regional, it actually is larger

The agreement includes no admission or determination of wrongdoing, Harden Healthcare, the owner of Voyager HospiceCare and Hospice of Kansas, said in a statement.

Harden Healthcare, according to the Austin (Texas) Business Journal, is the largest private employer in that city, with over 3800 employees and revenues of over $810 million.

Hospice of the Comforter

The Orlando Sentinel reported in late August,

The federal government is taking over a whistleblower lawsuit against the Altamonte Springs-based Hospice of the Comforter — a suit that alleges the nonprofit routinely over-billed Medicare for patients who didn't qualify as terminally ill, sometimes keeping them in hospice care for as long as five years.

These are allegations of course, but it turns out that both sides of the action agree on certain facts of interest,

Both sides agree that Hospice of the Comforter officials discharged a large number of Medicare patients after the federal government began scrutinizing the ballooning number of hospice patients nationwide.

In fact, Stone said, the initial sampling by government auditors showed Hospice of the Comforter had an error rate of 18 percent, just slightly over the 15-percent rate the government allowed and therefore triggering a second, more intense review.

That phase, in January 2010, revealed a troubling 77 percent denial rate, Stone said — meaning that Medicare officials believed the hospice was improperly billing the government in 77 percent of the cases it reviewed. According to the government, hospice care should be limited to patients certified by a hospice physician as having six months or less to live.

Meanwhile, though, an internal hospice committee did its own review of patients, discharging more than 133 of them and noting they were, 'no longer terminally ill,' the lawsuit states. Some had been designated 'FOB' for 'Friends of Bob [Wilson, the CEO of the hopsice],' and Wilson later insisted some be readmitted and their care billed to Medicare, the lawsuit says.

Let me just note that for someone truly terminally ill, the way to become no longer terminally ill is to die.

A column in the Orlando Sentinel suggested that the hospice CEO had a strong personal incentive to enroll patients who were not terminally ill,

there are facts not in dispute — such as Wilson's financial incentive to keep his patient counts high: bonuses of $50,000 every three months on top of his base salary of $120,000.

Again, maintaining lucrative compensation could be an inducement for hospice executives to sanction enrollment of patients who were not really terminally ill.
Summary

Hospices arose to provide compassionate care for among the most vulnerable of patients, the terminally ill.  Hospices began as mission oriented non-profit organizations, often affiliated with hospitals or religious groups.  However, the generous payments for hospice care provided by Medicare and commercial insurance, and the increasingly laissez faire supposedly "market-based" health care context lead to the growth of for-profit hospices, and the emulation of their management by ostensibly non-profit organizations.  In the Orlando Sentinel, Scott Maxwell used the example of the Hospice of the Comforter to assert

you've been duped when it comes to waste, fraud and abuse in America's health-care system.

Politicians love to rant about it. They often do so when explaining why they're about to cut your benefits.

They're right that fraud happens. But the individual scammers they portray as the problem are nothing compared to the systemic white-collar fraud perpetrated by corporations — and, yes, faith-based nonprofits.

This is America's dirty little health-care secret.

We all know health-care costs are soaring. But we have done little to address the organized fleecing — often because the fleecers are either campaign donors or nonprofits wrapped in a cloak of altruism.

In this country, you can go to prison for stealing a TV. But if companies get caught stealing millions from taxpayers, the fines are simply viewed as the cost of doing business.

We have made similar assertions about systemic misbehavior in the US health care system, and how failure of local through national government to impose any penalties on the individuals who authorize, direct or implement bad behavior just allow the problem to get worse. However, the consequences of increasing hospice enrollment (hence short-term revenue, and hence the compensation of top hospice executives) by enrolling patients who are not terminally ill go well beyond just increasing health care costs. As we have said before, enrolling patients into hospice who are not already really doomed to die soon denies them the possibility of treatment for new acute illnesses and worsening of chronic illnesses, which then could hasten their deaths. (Pretending those patients were terminally ill could have fooled their relatives into thinking those deaths were inevitable, instead of results of bad practice and potentially fraud.)

So the pattern of fraud now increasingly documented to be taking place in for-profit and even non-profit hospices is particularly reprehensible. It preys on vulnerable patients, and may cost some patients their lives who otherwise might have lived for a long time. This is a prime example of what goes wrong when our main health care policy seems to be based on letting the good times roll.

I hope that the realization that enrollment of patients who are not terminally ill into hospices can result in their untimely death may lead to some reconsideration of our experiment in lightly regulated, "market based" health care. Those who directly care for patients ought to be motivated by professional values, not short-term revenue.

A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions:

Jul 31, 2012
Only 26 Percent of Americans Want Electronic Medical Records, Says Xerox Survey

The subtitle is a rhetorical question:

When it comes to healthcare, are Americans resistant to change?

This is analogous to the refrain of calling physicians and nurses "Luddites" regarding their not happily and passively accepting today's clinical IT.  I addressed that issue at my post on pragmatist clinicians v. health IT hyper-enthusiasts at this link.

Jul 31, 2012

ROCHESTER, N.Y. – Americans routinely use electronic files to manage their finances, communicate with friends and family and even take college courses – but when it comes to medical records – only 26 percent want them digital. The findings come from the third annual Electronic Health Records (EHR) online survey of 2,147 U.S. adults, conducted for Xerox (NYSE: XRX) by Harris Interactive in May 2012. 

According to the survey, only 40 percent of respondents believe digital records will deliver better, more efficient care. That response fell two percent from last year’s survey, and matches the response reported in 2010. Overall, 85 percent of respondents this year expressed concern about digital medical records.

Americans have a healthy skepticism of putting their private information online to be hacked, of the disruptive effects of today's commercial health IT on their clinicians, and the costs of doing so.  This likely comes from common sense, reading and observation.

As one reader of this blog wrote:

Xerox kindly shared all three years of their annual Electronic Health Records (EHR) online surveys by Harris Interactive. The media, industry and government unrelentingly promote health technology as the latest, greatest best stuff. But the public ain’t buying it. They want smart phones, but they don’t want EHRs.

The Xerox article paternalistically continues:

“We continue to see a resistance to change from consumers – meaning providers need to continue to educate Americans on the value of EHRs,” said Chad Harris, group president, Xerox Healthcare Provider Solutions.

(Note the use of the 'EHR' acronym.  As I've written, the acronyms 'EHR' and 'EMR' are anachronisms used to describe what are no longer innocuous filing systems, but greatly intrusive enterprise clinical resource and workflow control systems.  I think the public increasingly understands that.)

This patriarchal statement by Chad Harris about "resistance to change" by "healthcare consumers" needing re-education is, in a word, depraved, because I think the person uttering the sentence knows better.  Let's define depraved:

Depraved (adj.):  morally bad or debased; corrupt; perverted

This statement implies is that health IT is a perfected technology without significant flaws, whose benefits are well-proven and whose drawbacks and risks are well understood.

Unfortunately, none of those are true.  From my May 2012 post on ONC's embarrassing "Health Data Palooza", worth repeating here, with hyperlinks:

• There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist;
• The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors;
• Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);
• The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);
• The roles of scientific discovery and anecdote have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, qualitative, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" extolling the virtues of HIT, written about at http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html).
• Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown as admitted by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;
• Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others;
• Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.)
• These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in reams of "legible gibberish" with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.

The article continues:

Despite consumers’ misgivings of the value of EHRs, caregivers [largely hospitals and healthcare systems who force it on their staffs and owned physician practices - ed.] are quick to adopt digital technology.  [Thanks to incentives and looming penalties - ed.] When asked how their healthcare provider recorded medical information during their last visit to a doctor or hospital, 60 percent of respondents – who have visited a doctor or hospital – reported that the information was entered directly into a tablet, laptop or in-room computer station versus 28 percent who reported the information was taken via handwritten notes. 

As the numbers don't justify the practice, even if the numbers as stated are valid, my response is:

So what?

To help caregivers do more with this patient information, Xerox is working with researchers at PARC, A Xerox Company, to explore EHRs as a gateway to a variety of healthcare innovation possibilities. The resulting technology tools will simplify back-office and front-line processes, reduce errors, and free up caregivers to spend more time and attention on day-to-day patient care.

The "possibilities" will accomplish all these things?  

Not only does that not follow logically, but where's the data, or is this simply wishful thinking? 

The latter "possibility that will come true" - "free up caregivers to spend more time and attention on day-to-day patient care" - is the most laughable.   These systems do anything but, as for example here regarding the the time costs of data acquisition and the time costs of data input.  I have yet to see serious studies that consistently demonstrate any time savings at all for clinicians.  Quite the reverse, actually.

Of course, the mandatory marketing puffery:

“A big part of PARC’s healthcare work for Xerox is using ethnography and other social science methods to observe and analyze actual work practices – not just what people say they do,” said Steve Hoover, CEO, PARC, A Xerox Company. “If there’s one thing that this survey tells us, coupled with our own experiences, it’s that you should never develop or deploy technology outside of the human context.”

Precisely what is being done now, and on a national scale in the 'National Program for IT in the HHS.'

Xerox, either you're part of the solution or part of the problem.

Which is it?

-- SS

How Many Legal Settlements Does it Take... to Lead to Real Change in Johnson and Johnson Leadership?

And the latest Johnson & Johnson settlement is (as described in Bloomberg/ BusinessWeek):

Johnson & Johnson (JNJ) will pay $181 million to resolve claims by 36 states that it improperly marketed and advertised the antipsychotic drugs Risperdal and Invega.

J&J and its Janssen unit settled claims that it promoted the drugs from 1998 through 2004 for uses not approved by the U.S. Food and Drug Administration. New York Attorney General Eric Schneiderman said today the accord is the largest multistate consumer protection-based pharmaceutical settlement.

'This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules,' Schneiderman said in a statement.

J&J agreed it won’t promote the drugs for off-label uses or tout them falsely.

Specific Bad Behaviors

The allegations were of the sorts of behavior that should make health professionals cringe,

Using speaker programs on unapproved uses, sham consulting programs for physicians, and lucrative agreements with doctors who prescribed off-label, J&J 'sought to enhance Risperdal’s off-label market penetration across a wide range of diagnoses and patient populations, according to Florida’s complaint.

So reading slightly between the lines, the behaviors included various ways to pay physicians ("sham consulting," "lucrative agreements") for prescribing drugs, providing physicians monetary incentives to violate the most core of their core values, putting the individual patient's welfare and needs ahead of personal enrichment. Why these were not labeled kickbacks or bribes is not obvious.

No Individuals Pay any Penalty

Nonetheless, as in nearly every other legal action by state or federal law enforcement against a big pharmaceutical company or other big health care company, the entire settlement involved no penalties to any individuals who may have authorized, directed or participated directly in the misbehavior. In fact,

The company, based in New Brunswick, New Jersey, settled 'to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process,' it said in a statement.

J&J didn’t admit wrongdoing or pay a fine or penalty.

The tough law enforcers claimed

The agreement 'sends a message to all pharmaceutical companies that these practices will not be tolerated,' Florida Attorney General Pam Bondi said in a statement.

Of course, there was another part to the settlement. The company promised not to do these sort of bad things again,

Bondi said Janssen agreed to several steps over five years. They include having policies to ensure that financial incentives aren’t given to encourage off-label marketing; sales and marketing employees can’t develop the medical contents of responses to health-care providers; and it must describe the effectiveness and risks of drugs in a balanced manner.

Should we believe them? Their record is not promising.

Earlier this year Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians about the very same drug at issue in this suit, Risperdal (look here). That was just the latest in a remarkable string of legal cases suggesting an ongoing pattern of unethical and illegal behavior by this very large health care corporation. As we wrote recently, this included
- Convictions in two different states in 2010 for misleading marketing of Risperdal, as noted above
- A guilty plea for misbranding Topamax in 2010
- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see this link for all of the above)
- Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post here)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
- More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
- Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this BusinessWeek story.)

One might think that the leadership on whose watch this all occurred would be in disgrace. There has been, however, no major changes in leadership of the company. The CEO who was in power during the time when these settlements, and much of the behavior leading to them, will be retiring, after earning huge compensation, and with a retirement package valued somewhere between $143 and $197 million (see this post). Rather than disgrace, he recently was put on the committee responsible for investigating JP Morgan Chase's $5.8 billion dollar trading loss (as reported by Bloomberg, via NJ.com).

Summary

As we have noted again and again and again, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved.

These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look here). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "grow a backbone" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.

As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?

At my Aug. 31, 2012 post "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" I wrote that healthcare IT vendor EPIC was advising customers in what to write in their "Public comments" regarding the proposed Meaningful Use Stage 2 Final Rule, the requirements of which permit financial incentives to be received by a user if met by an EHR.

It appears they may have been successful.

Note their apparent boilerplate "recommendations" regarding § 170.314(a)(9) - Electronic notes.  This comes from the numerous filings with the accidentally unredacted "Informational Comments for Organizations Using Epic (remove before submitting to ONC)" note, and others without.   Pay specific attention to the "Tertiary Recommendation":

Major Concern

As detailed in our introduction, we are significantly concerned that the scope of the certification program is endangering some of the goals of Meaningful Use by introducing unnecessary overhead and burden.

As electronic notes are not proposed as a Meaningful Use objective with the rationale that electronic notes are already in common use, we do not think certification on this criterion is necessary, and suggest removal. Introducing unnecessary certification criteria creates expense for ONC, certifying bodies, and EHR developers, and does not provide significant value to the marketplace.

Recommendation
Keep consistent with CMS and remove this criterion from the Final Rule.

Secondary Recommendation
If this criterion is retained in the Final Rule, we suggest that the criterion should be an optional certification for the same reasons, and we make the following suggestions:

We agree with your assessment that having notes be searchable provides increased value over notes that are part of a scan or other formats that are not able to be searched. Our experience shows that note search capabilities is complex with potential for innovation in how information is found and displayed. Prioritization of such capabilities is best left to the marketplace. Search is not essential to meet the not-proposed objective drafted by CMS. Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. Therefore, we suggest that search capabilities be excluded from certification.

Tertiary Recommendation
If this criterion is retained in the Final Rule and is not made optional, a reasonable requirement for certification would be the ability to search for a free-text string within a particular open note. Other search capabilities should be left as competitive differentiators within the marketplace. Specific certification requirements could interrupt innovative ways to do effective chart search and information display.

Informational Comments for Organizations Using Epic (remove before submitting to ONC)

We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.

Our comments [presumably, those above - ed.] stem from the fact that we believe that you prefer we focus our attention on the more sophisticated chart search feature you have requested in a future version.

The ability to search for a free-text string within an already open [on-screen] note is not of very much value (near useless perhaps?) compared to the ability to search an open patient's record for all notes that contain a string, or across a set of many records, for free-text strings or other values. Think Windows 7 "Search programs and files" at the Start menu, the MS Win XP add-on Windows Search 4.0 for Windows XP, or MacOS's Spotlight.

(Is there, I ask, a commercial EHR that cannot search for a free-text string within a "particular open note"?  Further, any web browser can search screen contents for text strings, I add, so if the EHR is using a browser, that feature comes as a freebie.)

Now note from the MU Stage 2 NPRM (Proposed Rule as in the Notice of Proposed Rulemaking) that appeared in the Federal Register on Mar. 7, 2012.  The relevant passage about note searching is highlighted in green:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991-AB82
Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology
AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services.
ACTION: Proposed rule.

§ 170.314(a)(9) - Electronic notes

• Electronic notes

MU Objective Record electronic notes in patient records.

2014 Edition EHR Certification Criterion § 170.314(a)(9) (Electronic notes)

The HITSC recommended a certification criterion similar to the 2014 Edition EHR certification criterion we propose at § 170.314(a)(9) (with specific reference to "physician, physician assistant, or nurse practitioner" electronic notes) to support the MU objective and measure recommended by the HITPC. CMS has not proposed the MU objective and measure for Stage 2, but has requested public comment on whether the objective and measure should be incorporated into Stage 2.

Consistent with our discussion in the preamble section titled "Explanation and Revision of Terms Used in Certification Criteria," we have replaced the terms "modify" and "retrieve" in the recommended criterion with "change" and "access," respectively. Additionally, we are providing the following clarifications for the electronic "search" capability. "Search" means the ability to search free text and data fields of electronic notes. It also means the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes. We believe that this certification criterion would encompass the necessary capabilities to support the performance of the MU objective and measure as discussed in the MU Stage 2 proposed rule.

Note the robust "search" capability proposed - the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes.

Now, finally, note the Final Rule:

On pg. 300 of final rule at http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf it says:
 

Stage 2 Measures:

Enter at least one electronic progress note created, edited and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.

Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH's inpatient or emergency department during the EHR reporting period.

Electronic progress notes must be text-searchable. Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.

pg. 553:

Enter at least one electronic progress note created, edited, and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.

Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH’s inpatient or emergency department during the EHR reporting period.

Electronic progress notes must be text-searchable. Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable notes under this measure.

It would appear, and readers, please correct me if I am mistaken, that the very short criteria specified here - "Electronic progress notes must be text-searchable" - would be satisfied by "the ability to search for a free-text string within a particular open note" per the vendor-authored Tertiary Recommendation, shown supra.

I've searched the MU Stage 2 Final Rule (Adobe Acrobat can do that, but I probably could have used Windows search itself depending on document length) seeking terms from the NPRM such as "search", "information across", "notes", "free-text" etc.  However, I cannot find anything approaching the NPRM § 170.314(a)(9) clarification regarding the meaning of "electronic search capability."

I ask:  what was the role of the Tertiary Recommendation received by ONC from multiple EPIC user organizations?

-- SS