An Open Letter to the Joint Commission on Their Fiduciary Responsibilities Concerning Health IT

An open letter to the Joint Commission. Emphasis in the original:

From: S Silverstein
Sent: Friday, October 14, 2011 9:21 AM
To: MGiuntoli, Anita; Chassin, Mark; Legaspi, Shirley; McKee, Ana; Schyve, Paul [Joint Commission leaders - ed.]
Cc: [State senator aware of the situation, who was seeking votes at a nursing home/ rehab center while my mother was being treated - ed.]
Subject: "Diary of EHR-Initiated Tragedy"

Dear Joint Commission,

Now that Medicare's [state] QIO has found my mother to have been a victim of care that "did not meet applicable professionally recognized standards of health care" (as at http://hcrenewal.blogspot.com/2011/10/there-are-still-some-medical-watchdog.html), I am making available an overall detailed account of what occurred to her. The account, though anonymous as to hospital, location, clinician ID's etc., is at this link:

http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary

I should let you know that the Drexel URL's readers are tracked (by IP only); in other words, I will be able to tell if JC looked at it or not.

It is my opinion that the JC and its leaders have a primary fiduciary responsibility to prevent such mishaps from occurring, through significantly tighter oversight of hospital's use of IT, which in reality are experiments on human subjects without informed consent.

Please consider yourselves informed of these views.

Sincerely,

Scot Silverstein, MD
Drexel University
Philadelphia, PA

I don't believe any further explanations are necessary.

Oct. 14, 2011 Addendum:

We've corresponded before, the JC and I, after my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in the Journal of the American Medical Association in July 2009, JAMA. 2009; 302(4):382. doi:10.1001/jama.2009.1041, and again after my mother was injured in 2010.

In that 2009 JAMA letter I'd opined:

... When hospital leadership signs agreements specifically excluding the sharing of information about HIT defects and user complaints, it seems they have violated these standards. [That is, Joint Commission Safety Standards such as LD.01.03.01 and LD.03.04.01 that I cited earlier in the letter; see above link to an extract of the letter - ed.] Nondisclosure seems to violate the standards’ spirit and letter.

Signing such HIT contracts may also represent a violation of the legal and fiduciary duties of hospital administrations to protect not just patients but also employees from undue physical and legal jeopardy. Placing the entire burden of liability for HIT malfunctions on clinicians, and not obtaining informed consent from patients for use of these systems, seems a major deviation from the responsibilities of persons with legal and fiduciary obligations to discharge faithfully a responsibility of trust toward others, including safety.

This was nearly a year before my mother became injured.

-- SS

Oct. 16, 2011 addendum:

See what the President of the American College of Physicians (ACP) thinks about today's health IT via my post here.

-- SS

Another Month, Another Set of Legal Settlements, Deferred Prosecution Agreements, and Jury Findings Adverse to Large Health Care Corporations

Another month, another series of adverse legal rulings suggesting misbehavior by large health care organizations.  In alphabetical order,...

Baxter, McKesson, Teva Pay Punitive Damages

As reported by Bloomberg,

A jury said Teva Pharmaceutical Industries Ltd. unit and two other drugmakers must pay $162.5 million in punitive damages for selling the anesthetic Propofol in a way that led three colonoscopy patients to develop Hepatitis C.

Jurors in state court Las Vegas ordered Teva Parenteral Medicines Inc., Baxter Healthcare Corp. and McKesson Corp. to pay so-called punishment damages over sales of the anesthetic in vials large enough to be reused by doctors. Anne Arnold, Richard Sacks and Anthony Devito contend they contracted Hepatitis C from reused vials during colonoscopy procedures. They had sought more than $700 million in damages.

It’s the second punitive award against Baxter and the unit of Petach Tikva, Israel-based Teva over a 2008 hepatitis outbreak in Nevada tied to Propofol. The first case resulted in a punitive verdict of more than $500 million against the drugmakers. Teva has agreed to cover all damage awards arising from the Nevada cases on behalf of Baxter and McKesson.

In particular,

The patients’ lawyers allege Teva intentionally sold Propofol in jumbo-sized vials to encourage doctors to reuse them, even with the risk of spreading blood-borne diseases such as hepatitis, an incurable liver disease.

So the allegations are that the company intentionally put financial gain ahead of the safety of patients.

Boston Scientific Settles Over-Billing Allegations

Again per Bloomberg:

Boston Scientific Corp.’s Guidant LLC unit will pay $9.25 million to settle a whistleblower’s claim that the company over-billed the U.S. and private hospitals for heart pacemakers and defibrillators.

The details:

Guidant allegedly reneged on credits owed to the U.S. Department of Veterans Affairs for replacement of units still under warranty and is accused of over-charging hospitals for the devices, causing them to over-bill Medicare, according to an e-mailed statement from the Justice Department.

Note that we have quite a extensive files on Boston Scientific, and on Guidant, now its subsidiary.

Hil-Rom Settles Fraud Allegations

Reported by the Knoxville News-Sentinel:

Federal prosecutors announced Tuesday a $41.8 million civil fraud settlement in a 'whistle-blower' lawsuit against international medical equipment supply company, Hill-Rom Company Inc.

The results also were that

As part of the settlement, Hill-Rom has entered into a five-year 'corporate integrity agreement,' in which the firm will face close scrutiny by federal officials, Killian said.

The allegations were:

'Hill-Rom submitted false claims for medical equipment for patients who did not qualify for the equipment, including patients who had died, were no longer using the equipment or had been moved to nursing homes,' [US Attorney Bill] Killian said.

In particular,

The lawsuit alleged the firm was ripping off Medicare with its faulty billing practices. According to the lawsuit, unsealed Tuesday, Hill-Rom offered its sales representatives $200 gift certificates and 42-inch televisions as reward for boosting billings and, in 2001, laid off the lion's share of staff dedicated to ensuring compliance with Medicare rules.

Note that this suggests a pattern of providing incentives to employees who "make their numbers," no matter how they do so. We have seen how making the financial numbers seems to take precedence over all else, including patients' well-being, in many contemporary health care organizations.

Maxim Healthcare Settles Fraud Allegations

In a story in the Baltimore Sun,

A Columbia-based health care firm has agreed to a $150 million settlement with the federal government and 43 states to resolve criminal and civil charges that it submitted claims for millions of dollars of work that it did not perform and operated offices that were not properly licensed, officials said Monday.

A five-year federal investigation found that Maxim Healthcare Services Inc., one of the country's largest providers of home healthcare services, submitted $61 million in false claims for services to the federal government's Medicaid and Veterans Affairs health programs over an 11-year period from 1998 to 2009.

Investigators said managers and workers at Maxim repeatedly modified time sheets and documents to cover up the fraud, creating a culture in which submitting false claims became 'common practice.'

The settlement was of criminal as well as civil charges:

The settlement includes a $20 million criminal fine and $130 million in civil settlements.

It will also involve a deferred prosecution or corporate integrity agreement:

In addition to the fines, Maxim also has been charged criminally with conspiracy to commit health care fraud. But the company could avoid conviction if it meets requirements outlined in the settlement.

Unlike many such cases, this one involved criminal charges for and guilty pleas by some people involved in the wrong-doing, in this case, middle managers:

Several regional account managers, a home health aid and a clinical services director also pleaded guilty to criminal charges, government officials said. They could face as much as $250,000 in fines and jail time for their roles in the fraud.

Another atypical result was that the CEO who presided over the misbehavior actually suffered some consequences, although he did not have to pay fines for face criminal charges,

Maxim officials said they take full responsibility for the violations. The company said it hired a new CEO in 2009 and changed its business practices to protect against a repeat.

ProPublica published an article at the same time which noted that Maxim's practices had come into question before,

A different set of problems involving Maxim came up during a ProPublica investigation into the oversight of registered nurses in 2009. We identified several nurses who were hired by the Maryland-based company despite having a record of problems.

Although that previous article did not mention the company's name:

The articles focused on how regulators across the country did little to scrutinize troubled nurses who crossed state lines to continue working. Our earlier stories did not identify Maxim by name.

We have noted that organizations which misbehave once are likely to misbehave again. This may stem from an organizational culture that puts revenue ahead of ethics and patients' and the public's health, and the lack of negative consequences that people who respond to the resulting positive financial incentives are likely to suffer.

Medicis Settles Shareholder Class-Action Lawsuit

Noted by the Arizona Republic,

Medicis Pharmaceutical Corp. and its auditing firm, Ernst & Young, have agreed to pay $18 million to settle a shareholder class-action lawsuit stemming from the pharmaceutical company's financial statements.

The shareholders alleged that Medicis was not honest about its financial affairs:

The shareholders' lawsuit stems from Medicis' announcement in September 2008 that it would restate earnings from 2003 through the first half of 2008.

Shareholders alleged that Medicis offered its wholesale customers generous return policies for prescription drugs as part of an effort to inflate the company's revenue. Medicis would accept returned products that were expired or about to expire at either no cost or substantial discounts to the wholesale customers, according to the lawsuit.

Summary

The constant march of legal settlements by, jury verdicts against, and in some cases criminal convictions of or guilty pleas by large health care corporations indicate how common misbehavior by such organizations has become. Since it is likely that much misbehavior does not lead to publicly announced legal actions, what is published can only provide a floor for an estimate of how common it is. The march, which we have been documenting since starting Health Care Renewal, shows how sleazy and often corrupt health care has become, and how that sleaziness and corruption is prevalent not just among small players, but among the biggest and richest health care organizations, and their top leaders.

One reason the situation continues to be so bad is that while the unethical behavior does sometimes result in pontificating by the civil authorities, and fines that may only be costs of doing business, it rarely leads to meaningful negative consequences for those who authorized, directed or implemented it. This was noted in the reporting of the Maxim Healthcare case above. For example, in the Baltimore Sun article we found,

One watchdog group called the penalty a drop in the bucket for a company that had $2 billion in reimbursements from 2003 to 2009.

'That is hardly crippling,' said Joe Newman, a spokesman for the Project on Government Oversight, which tracks government contractors. 'It is certainly something that stings Maxim's pocketbook, but they will be fine after that.'

'They won't be barred from the Medicaid program. That would hurt them.'

Also, Sun columnist Jay Hancock wrote:

Corporations are happy to be treated as people under the law, as we know from recent court decisions. They can own property. They can seek redress in Congress and the courts. They can make huge political contributions.

But when it comes to being penalized for cheating the government, corporations quickly abandon their personhood and go back to being abstract blobs.

'I don't know about you, but if I hired a contractor to work on my house and he charged me a ton of extra money for work he didn't do, I wouldn't use that contractor again,' Minnesota Sen. Al Franken said in Congress a few months ago. 'And I would make sure my friends knew not to use them either. It seems like the same should be true of government contractors.'

But that is often not the case. For years, government agencies have not vigorously enforced the law when doing so might inconvenience big corporations and their well-paid executives. Maybe this lenience stems from the loony philosophy of former Chairman of the Federal Reserve Alan Greenspan, who was once regarded as some sort of economic genius, who seemed to think that fraud cannot occur in his idealized idea of a free market, because somehow all bad actors would become widely known and therefore all counter-parties would avoid them. In an article in Stanford Magazine,

The influential Greenspan was an ardent proponent of unfettered markets. Born was a powerful Washington lawyer with a track record for activist causes. Over lunch, in his private dining room at the stately headquarters of the Fed in Washington, Greenspan probed their differences.

'Well, Brooksley, I guess you and I will never agree about fraud,' Born, in a recent interview, remembers Greenspan saying.

'What is there not to agree on?' Born says she replied.

'Well, you probably will always believe there should be laws against fraud, and I don’t think there is any need for a law against fraud,' she recalls. Greenspan, Born says, believed the market would take care of itself.

For the incoming regulator, the meeting was a wake-up call. 'That underscored to me how absolutist Alan was in his opposition to any regulation,' she said in the interview.

It is a measure of the insanity of recent years that one of the chief leaders of government economic policy did not believe there was any need for laws against fraud.

It appears that this daft idea has carried over to and still influences how many in government and out deal with health care. However, as we have ddiscussed, health care is not and probably cannot ever be an ideal free market. Also, in health care, most of the bad actions remain anechoic, and in many cases it may be hard for counter-parties to avoid bad actors because they may dominate the market. Also, it may be those that make decisions about whether to deal with particular organizations may be executives, and sometimes health care professionals who have become indifferent to the ethical issues.

As I have said again and again, pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.

So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

"24", This Computer Project Was Not

A fascinating case study of IT failure in another life-critical domain has come to my attention.

I think if the words "FBI" were replaced with "hospitals" and "healthcare IT", this could be a study of IT failure in the latter organizations. Many of the familiar issues are there:

The Failure of Virtual Case File and the FBI

Background

The FBI first sought to embrace technology in the 1980s during the onset of computer availability and hoped to have a paperless office where agents could quickly pull up case files, information, and photographs at the comfort of their desks without having to sift and sort through numerous paper files. The infrastructure in that time was limited to text based search engines and there were no provisions for photo storage or the ability to scan written reports. As a result, the FBI found its agents decided not to rely on the existing technology and were reverting back to paper.

After the attacks on September 11, 2001, the FBI was placed under scrutiny for being ineffective and inefficient in its operations due to the time it would take to share information with other law enforcement agencies, locate reports, and transmit them from one location to another (usually done via fax or by mailed CDs). To combat this, the FBI developed a plan known as Trilogy, which aimed for three primary goals: A new computer network, personal computers for most agents, and an online criminal database that would be titled Virtual Case File (VCF). An external contractor by the name of Science Applications International Corp. (SAIC) was contracted in June 2001 to begin the project with an estimated schedule of three years for completion and a first year budget of $14 million. The project continued until early 2005 (7 months over schedule), at which time the project scope had expanded by 80% with costs of $170 million and was riddled with issues. Ultimately, in early 2005, the project was cancelled but not after escalation and persistence on the part of the FBI.

The Problems and Failure of VCF

The FBI wanted SAIC to create the database from scratch instead of using off-the shelf Oracle programs that could have been customized. A study by the National Research Council (NRC) after the planned 3-year period in late 2004 was conducted to gauge the success of the program, and while the first two goals had been achieved (personal computers for most agents and the creation of a new network), VCF was found to be problematic and incomplete. The project plan was incomplete and there were no monitoring controls regarding finances or the schedule. The FBI threw quality out the window by wanting to bypass testing and release the product upon its ready date.

However, VCF failed the most basic functionality tests under the NRC and had not included network management, security, and storage systems, or basic sorting capabilities. The study also found that most of the FBI's skilled managers had left for the private sector and there were little to no individuals who had the IT experience or knowledge to interact effectively with contractors to achieve what was needed. The definition and scope of operations and processes were ultimately entrusted to SAIC who were outsiders.

In an attempt to salvage the project, the FBI immediately hired a federally funded R&D firm (Aerospace Corp.) costing $2 million to conduct an assessment of the project who concluded that the project needed to be scrapped and shut down due to the severity of the software issues. Upon investigation by Congress, there was a lack of financial controls and safeguards on the part of the FBI, enabling SAIC to continue to develop a program which was lacklustre and failed to meet objectives.

200 programmers from SAIC were used on the project when only a dozen were required and SAIC was not being properly monitored by the FBI. They felt as long as money was being funnelled to them by the government on the project, they did not need to be responsible for the effectiveness or viability of the program [was there a "hold harmless" clause as in health IT? - ed.] they were building and fired staff who expressed concerns over the direction of the program. [They must have been Luddites and IT skeptics who just refused to change the way they do things - ed.]

Further, the FBI took a trial by error approach to the project without truly understanding their end goal and without setting benchmarks for evaluating the progress of the project and took a nearly hands off approach by entrusting SAIC entirely. SAIC claimed the FBI were indecisive in what they wanted and there had been 19 government personnel changes over the project tenure which brought on scope creep and the focus of the project in a state of flux, in addition to a clear lack of leadership. A further $17 million was then spent by the FBI to perform more rigorous testing to try to salvage the project once more, which was another missed opportunity to cancel the project. It was only in early 2005 that the decision was made by Congress to terminate the project.

Source: Eggen, Dan; Witte, Griff. 'The FBI Upgrade that wasn't'. August 8, 2006. Website: http://www.washingtonpost.com/wp-dyn/content/article/2006/08/17/AR2006081701485.html (accessed on November 7, 2009).

"24" this was not.

Chloe O'Brian, where were you?

In the FBI's case, the failure exposes us to potential crime. In a hospital's case, the stakes are even more personal.

Even worse, at least here Congress intervened; health IT is a virtually unregulated industry and nobody is minding the store.

The UK's National Programme for IT (NPfIT) in the NHS paid the price of failure through problems such as above.

Will the "NPfIT in the HHS" meet a similar fate?

-- SS

Oct. 13, 2011 Addendum: where have we seen SAIC before?

How about here?

Case 3: Bedlam

Meanwhile, Science Applications International Corporation disclosed that computer backup tapes containing medical data for 4.9 million military patients [that number also amounts to almost 2% of the total U.S. population - ed.] had been stolen from an employee’s car in San Antonio. The data included Social Security numbers, clinical notes, laboratory test results and prescriptions.

-- SS

Health Care's "99 Percenters"

As Occupy Wall Street has gone from an obscure protest covered only on blogs and social media to a national phenomenon, the apparent parallels between the issues it is raising and the issues we have been raising in health care grows.

99 Percenters

A growing number of protesters are calling themselves the "99 Percenters," (Alter, Jonathan.  Why Occupy Wall Street Should Scare Republicans.  Bloomberg, October 6, 2011.  Link here) referring to those who are not in the top 1% of earners.  (The top 1% of income is clearly greater than $250,000/ year [see 2009 census data on US household income here], and likely around $380,000 a year [based on the distribution of income reported on tax returns here.]) 

In health care, nearly all who are paid more than $380K/ year are either proceduralists (some medical sub-specialist physicians, and some surgeons, again mainly sub-specialist), or managers and executives of health care organizations.

Health Care's 1% 

We have been discussing since 2007 how the inequality among physicians' incomes favoring those who do procedures over primary care and other "cognitive" physicians has been driven not by the market, but by regulatory capture.  The fees paid for all physicians services by Medicare, a fee schedule adopted without question or major changes by nearly all insurers, are set through the Resource Based Relative Value System (RBRVS) by the US Center for Medicare and Medicaid Services (CMS).  CMS, in turn, gets virtually all its input on these fees from the RBRVS Update Committee (RUC), a private committee of the American Medical Association (AMA), made up largely of proceduralists, whose deliberations are secret, and whose membership has been secret until recently.  See here for most recent posts.  Note that the CMS' peculiar relationship with the RUC is now subject of a lawsuit that accuses this relationship of violating the Federal Advisory Committee Act (Klepper B, Kibbe D. A legal challenge to CMS' reliance on the RUC.  Health Affairs Blog, August 9, 2011.  Link here) 

The real top earners in health care, however, are not physicians, but executives of big corporations, non-profit and especially for profit.  We have discussed endlessly how huge their compensation may be, and how it seems unrelated to any aspect of their own or their organizations' performance, especially not to how much they benefit patients' or the public's health.  Furthermore, we have noted how executives have prospered even when their management seems overtly hostile to the health care mission, when it leads to ethical missteps requiring legal settlements, or even guilty pleas or verdicts to criminal charges. 

So health care's "99 percenters" ought to be angry at the top 1%.

The Power of Finance

Furthermore, the Occupy Wall Street protesters are not merely upset with the upper 1%, but particularly outraged by those in the financial sector, which "with regulators and elected officials in collusion, inflated and profited from a credit bubble that burst, costing millions of Americans their jobs, incomes, savings and home equity."  Then, "the initial outrage has been compounded by elected officials' hunger for campaign cash from Wall Street, a toxic combination that reaffirmed the economic and political power of banks and bankers, while ordinary Americans suffer.  Extreme income inequality is the hallmark of a dysfunctional economy, dominated by a financial sector that is driven as much by speculation, gouging and government backing as by productive investment." (Anonymous. Protesters against Wall Street.  NY Times, October 8, 2011. Link here)

In another report, the protesters "unite around a common theme: bankers are ripping off America.  Two secondary themes also emerge....  One is that the super rich own the politicians.  The other is that the news media, almost across the board, view events through the eyes of the super rich." (Johnston DC. Occupy Wall Street.  Reuters Blogs, October 7, 2011.  Link here.)

Finance's Links to Health Care

We have noted parallels between the effects of Wall Street and health care on the economy.  Furthermore, we have noted active ties among Wall Street and health care organizations. (Look here for examples.)  Top executives and board members of some of the financial firms most obviously responsible for the global economic collapse/ great recession have served on boards of trustees of top medical schools and academic medical centers, and their parent universities.  The top leaders of medical schools, academic medical centers, and their parent universities have served on the boards of such financial firms.  There are also board interlocks among Wall Street firms and all sorts of health care corporations.  The corporate culture of Wall Street and health care have long overlapped. 

We have further noted how the leadership of big health care organizations has deceptively influenced policy, particularly through stealth health policy advocacy.  Meanwhile, until the last few years, much of health care dysfunction has been anechoic.  Now the media is beginning to report some of the abuses.  Little about them appears, however, in the medical and health care literature that health care professionals are likely to trust more than news media. 

Summary

We have frequently suggested that true health care reform requires reform of health care leadership and governance.  We need leaders who understand the health care context, uphold health care professionals' values, and put patients first.  We do not need leaders who are ill-informed, incompetent, self-interested, conflicted, or corrupt.  We need governance that is accountable, honest, transparent, ethical, and again puts patients first.  Maybe to do that we will have to "occupy health care."

In any case, it is time for health care's "99 percenters" to stand up for their patients and the integrity of their values. 

A Diary of EHR-Initiated Tragedy

"What you cannot anticipate, you cannot dread." - The Fire Rose

I've realized that these past posts, when integrated for an upcoming investigation, tell a story that is probably not uncommon in hospitals today. They form a sort of Diary of EHR-Initiated Tragedy.

I fear that these problems will become far more commonplace under the government "incentives" and penalties for "non-meaningful" users of "certified" health IT.

(Definitions: certified = 'the IT has the features we mandate to gather the data we want, not that the features have to work well, or that the IT is safe'; incentives = 'take our meager dollars and use this IT the way we mandate, or we will punish you by cutting your Medicare reimbursement, even though your quality of care might be equal to or better than those using IT.')

Here are the posts, in chronological sequence as they were written:

1. "On EHR Warnings", http://hcrenewal.blogspot.com/2011/07/on-ehr-warnings-sure-experts-think-you.html

2. "The Issues at This Site, Started in 1999, Are Not Academic or Theoretical. My Own Mother Was Maimed by a Health IT-Related Problem Last Year", http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=bcs

3. "Saving My Mother From Being Maimed Twice. MAUDE Adverse Event Report - Life Threatening; Hospitalization Required", http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552

4. "Saving My Mother Again. EMR Problems? No, They're Merely Anecdotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits", http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html

5. "Saving My Mother yet Again. EHR Legible Gibberish - Another Example, the ED EHR Allergy List - And Legal Threats for Exposing Problems", http://hcrenewal.blogspot.com/2011/03/ehr-legible-gibberish-another-example.html

6. "My mother passed away", http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html

7. Aftermath (part 1, more surely to come) - "There Are Still Some Medical Watchdog Organizations That Call a Spade a Spade", http://hcrenewal.blogspot.com/2011/10/there-are-still-some-medical-watchdog.html

8. [added 11/14/2011] "EMR Defects That Injure and Kill, and Litigation: A Hospital Is Paying a Huge Hourly Rate for This?", http://hcrenewal.blogspot.com/2011/11/emr-defects-that-injure-and-kill-and.html

This is a cautionary tale regarding one of the biggest non-informed consent-grounded medical experiments in history.

-- SS