Tuesday, August 9, 2016

More on uncoupling clinicians from EHR clerical oppression

At my August 6, 2016 post (link) I wrote of my belief that "best practices" for EHR evolution call for:

... a return to paper (specialized forms depending on the setting) for clinical data capture by busy doctors and nurses, and data entry into a computer via clerical personnel.

I presented a late 1990's real-world experiment in creating such a system for invasive cardiology in the Delaware hospital system, Christiana Care Health System, where I was CMIO at that time.

As at the links http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story and https://web.archive.org/web/20140316024627/http://cci.drexel.edu/faculty/ssilverstein/scotsilv/invascard.htm (the latter a May 2002 article in the journal "Advance for Health Information Executives" written by myself and the project executive sponsor at the time), the "experiment" was a deliberate move away from the "doctors as clerical employees" article-of-faith of the health IT enthusiasts.

Enthusiasts seem to ignore the downsides and emphasize a (seemingly) sensible strong belief about efficiency, one of whose principles is that paper must be abolished in medicine.  Is work towards that end beneficial, or deleterious, to the clinical mission?

In fact, an attempt to implement such a paperless system, "Apollo" as the commercial system was known, in a cath lab performing 6,000 procedures/year proved impossible.  The busy clinicians, doctors, nurses and technicians simply did not have enough time to enter data directly into a computer.  Maneuvering around a computer application, dealing with its designber-centric menus, drop-downs, icons, widgets, annoying messages, input limitations, outright crashes with data loss, etc. was both inappropriate, and in fact impossible, in such a setting.

In 2016, one of the largest complaints of hundreds of thousands of U.S. physicians and nurses is that they spend more time interacting with the computer than with patients.  Patients complain they cannot get eye contact from clinicians - who are tethered to a computer screen entering data - during "live" encounters.

It is my belief there is no solution to this problem other than, where appropriate and advantageous, decoupling clinicians from data input and returning to paper for data entry, that is, specialized forms as in the aforementioned post.  Data input needs to be returned to clerical personnel as in the aforementioned invasive cardiology system.

The output side (with, of course, significant user-centered redesign) can remain computerized; as long as the paper forms are also made available via document imaging.

The forms for invasive cardiology looked like this, and were subject to revisions as needed.

Physician's data collection form, side 1.  Click to enlarge.
Physician's data collection form, side 2
Cath technician/nurse's data collection form, side 1
Cath technician/nurse's data collection form, side 2

The EHR itself was freed from "legacy" limitations regarding rapid customization, essential in medicine.  It was designed with the ability to rapidly incorporate changes and modifications to the dataset as needed, matching the changes to the forms.

Below I am showing some of the reports that this system produced regularly, as designed by the team of programmers, executives and cardiologists, under my medical informatics leadership. I used to do "real" informatics, e.g., leading the data modeling of entire clinical subspecialty domains and developing advanced IT based on those models, until seeing that the commercial sector was damaging the field of HIT, and medicine itself, with horribly bad health IT leading to letters such as the January 21, 2015 letter to HHS at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.  It was then, in the early 2000s, that I turned my attention to writing about the industry's deficits.

The major advantage of the cardiology reports shown below concerned accuracy, including the case report itself whose language and organization was also developed for optimal clinical organization and  readability -- unlike the reams of "legible gibberish" that emanates from commercial EHRs then and today.  See my post "Two weeks, two reams" at lhttp://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html for more on that issue.

Quality data input into the system, being freed from the accuracy-impairing aspects of busy clinicians as clerical employees, and the resultant reports saved the organization close to $1 million in the first year and led to a better understanding of what worked and what didn't in treating blocked coronary arteries.

Click to enlarge:

Some statistical reports, and sample computer-generated case report front page






An evaluation of the project by the national organization, the Society for Cardiac Angiography and Interventions, was that the accomplishments were "exceptional."





All this was achieved without direct clinician data entry - and deliberately so due to the distractions of that process having failed in the same setting in prior organizational attempts, without medical informatics expertise.  Perhaps, more accurately, I should say "medical informatics expertise in someone who also thinks critically about all issues involved, including adverse effects, of IT."  Clinicians could supplement each section of the forms data if needed via dictation, which was directly transcribed by humans into the cardiology server.

"Clerical work for clerical employees, clinical work for clinicians" was the theme of the project.

Breaking from the belief that paper is to be abolished at all costs was the key to creating really useful and well-accepted health IT, even in this exceptionally busy critical care setting.  It was still being used over a decade later, ca. 2008 and may still be now.  I have not been back for a visit since then.

One argument might be made that hospitals cannot afford enough clerical employees to do all the data input.  I maintain that, with hospitals spending upwards of $100 million for EHRs, and with the data being used and sold profitably by a wide variety of stakeholders who contribute nothing for the medical data they obtain (EHR makers, insurers, regulators to name just a few), transcriptionists could be afforded.

Of course:

Physicians with simply too much free time on their hands - the majority, it might seem, based on the behavior of some of the EHR enthusiasts and government pundits - and who enjoy giving away the fruits of their labor for others' profits could still enter data directly into the computer.  If they want to.

I note that if physicians really were empowered, the current status quo of clinicians as (unpaid) data-input personnel for those who profit from the data likely would never have come to pass.

Entering orders would still be done by clinicians, although that process and the process of alerts and reminders also needs a major reworking, such as use of advanced NLP to allow a more natural input of orders.

In summary, in the late 1990s the mantras of eliminating paper from medicine, and of clinicians needing to perform clerical work, were challenged and shown to be injurious to health IT progress in a critical care setting, invasive cardiology.

The lessons learned are more valuable today as they were then, considering that the health IT "experiment" is facing significant opposition today, with significant clinician rancor.  The CEO of the American Medical Association perhaps summed it up best when he referred to HIT as "the digital snake oil of the early 21st century" as at http://www.ama-assn.org/ama/pub/news/news/2016/2016-06-11-a16-madara-address.page.

These are unfortunate and undesired positions for the AMA CEO, and for the aforementioned medical society leaders as expressed in the letter to HHS to express, but this development has its real-world reasons.

Correction calls for modifying/softening cybernetic-enthusiast ideas like "paperless" and a more appropriate allocation of computer-related tasks.  Refocusing on "Clerical work for clerical employees; clinical work for clinicians" would be a good start.

-- SS

Monday, August 8, 2016

Weird emails from Independence Blue Cross via its IT outsourcing partners: showing yet more health IT industry trust-destroying incompetence

In the past week I've received two emails that made me highly suspicious of medical/insurance identity theft.

The emails came from Independence Blue Cross, ibx.com, into the email account I receive normal mailings from them, and seemed to indicate someone had created an unauthorized user account (I redacted my email address below):

Aug. 5, 2016:

From: noreply@ibx.com
Date: Fri, Aug 5, 2016 at 7:19 PM
Subject: User Created
To:
[my email address redacted]

User Created With UserId - userId20392, Password - password20392

July 27, 2016: 

From: noreply@ibx.com
Date: Wed, Jul 27, 2016 at 1:59 PM
Subject: User Created
To: [my email address redacted]

User Created With UserId - userId1546, Password - S04bd9u3tR

These userid's and passwords did not work at ibx.com's website, but my concern was that, if these were false accounts, the creator could have logged in and changed the password.

After the first email I left a message with the IBX fraud line, but heard nothing in response.

The metadata (IP headers) of the messages looked like this (I redacted my email address):

Delivered-To: [my email address redacted]
Received: by 10.237.44.68 with SMTP id f62csp1992388qtd;
Fri, 5 Aug 2016 16:20:27 -0700 (PDT)
X-Received: by 10.36.77.145 with SMTP id l139mr7340323itb.19.1470439227798;
Fri, 05 Aug 2016 16:20:27 -0700 (PDT)
Return-Path:
Received: from cnxsgusgma01.cnxuat.com ([216.183.110.200])
by mx.google.com with ESMTP id q123si19839234iof.67.2016.08.05.16.20.27
for ;
Fri, 05 Aug 2016 16:20:27 -0700 (PDT)
Received-SPF: softfail (google.com: domain of transitioning noreply@ibx.com does not designate 216.183.110.200 as permitted sender) client-ip=216.183.110.200;
Authentication-Results: mx.google.com;
spf=softfail (google.com: domain of transitioning noreply@ibx.com does not designate 216.183.110.200 as permitted sender) smtp.mailfrom=noreply@ibx.com
Received: from IBCSGUSGAA01.cnxuat.com ([192.168.230.147]) by cnxsgusgma01.cnxuat.com with Microsoft SMTPSVC(8.5.9600.16384);
Fri, 5 Aug 2016 19:19:39 -0400
Received: from ibcsgusgaa01.cnxuat.com ([127.0.0.1]) by IBCSGUSGAA01.cnxuat.com with Microsoft SMTPSVC(8.5.9600.16384);
Fri, 5 Aug 2016 19:19:58 -0400
From: noreply@ibx.com
To: [my email address redacted]
Message-ID: <1180377472 .11989.1470439198021.javamail.ibcsgusgaa01="" ibcsgusgaa01="">
Subject: User Created
MIME-Version: 1.0
Content-Type: text/plain; charset=us-ascii
Content-Transfer-Encoding: 7bit
Return-Path: noreply@ibx.com
X-OriginalArrivalTime: 05 Aug 2016 23:19:58.0024 (UTC) FILETIME=[E1DD4C80:01D1EF6F]
Date: 5 Aug 2016 19:19:58 -0400

User Created With UserId - userId20392, Password - password20392

After the second, I called IBX.  I was told it is a "malfunction", that these emails were not anything nefarious, other subscribers were affected, and that it "would be corrected soon."

I had already looked up the "Received from" header cnxsgusgma01.cnxuat.com [216.183.110.200]:

# ARIN WHOIS data and services are subject to the Terms of Use
# available at: https://www.arin.net/whois_tou.html
#
# If you see inaccuracies in the results, please report at
# https://www.arin.net/public/whoisinaccuracy/index.xhtml
#
#
# The following results may also be obtained via:
# https://whois.arin.net/rest/nets;q=216.183.110.200?showDetails=true&showARIN=false&showNonArinTopLevelNet=false&ext=netref2
#

Connecture, Inc. INFLOW-7524-7780 (NET-216-183-110-192-1) 216.183.110.192 - 216.183.110.255
Inflow Inc. INFL-AR-1 (NET-216-183-96-0-1) 216.183.96.0 - 216.183.127.255

Other IP's in the header appear to be of local (internal) workstations at the companies involved.

Who are these mysterious companies from which these emails seem to have originated?


Connecture, Inc:
http://www.connecture.com/the-connecture-difference/

Health insurance has entered the consumer age. Be ready. (We are.)

While there is almost universal agreement that health insurance will predominantly be distributed online in the near future, few American consumers have yet to experience it. In fact, most Americans have very little experience shopping for health insurance at all – let alone while making sense of numerous and often deceptively similar plans.

All of that is changing. Reform, the health insurance industry’s efforts to become more efficient, and Americans’ affinity for doing business online are all converging in the form of health insurance exchanges that present users with unprecedented freedom of choice.

Choice, of course, leads to questions. Which plans does my doctor participate in? Do they address my health needs? What about my family and my children? What happens if I need to go to the emergency room? How much will it cost – not just this month but year round? Am I eligible for a subsidy, and if so how much? In short, what’s the best plan for me and my family?

In health insurance, there are no cookie-cutter answers. That’s why health insurance exchanges and online distribution systems must do far more than enable consumers to enroll for coverage.

That’s where we come in. For more than 15 years we’ve focused on a singular goal: To create online systems and exchanges that empower Americans to choose the right health insurance plan online with confidence the first time, and every time.

Inflow Inc.
http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=105889

As of January 4, 2005, Inflow, Inc. was acquired by SunGard Availability Services, Inc. Inflow, Inc. provides facilities-based information technology outsourcing solutions to companies with critical business and network applications. The company offers its services in three primary lines: application hosting and management, business continuance and disaster recovery, and enterprise data-center management. Its application hosting and management services include application hosting and colocation, multi homed internet access, security services, application and infrastructure management, and network and system development. The company’s business continuance and disaster recovery services consist of business continuance planning/consulting, managed storage services, and content distribution services. Inflow’s enterprise data-center management services comprise onsite data-center management, operational support system management, data-center development, data-center audit services, data-center migration assistance, and business process documentation. Inflow, Inc. was founded in 1997 and was based in Thornton, Colorado.

Emphases mine.

So, perhaps millions of Independence Blue Cross customers are receiving emails that would reasonably cause suspicion in this day and age for identity theft, from companies that gloriously promise:

To create online systems and exchanges that empower Americans to choose the right health insurance plan online with confidence the first time, and every time.

To provide facilities-based information technology outsourcing solutions to companies with critical business and network applications

Confidence is the last thing the emails I received on behalf of ibx.com inspire in me.

If this information is being spilled (to the subscriber's own email account, but who knows where else?), I can only fear that other information is not quite secure, and wonder if these "ghost accounts" are just a glitch, or insiders spying on PHI, or other effects of either massive bugs or hacker attacks.

IT companies and companies that outsource their critical IT to others (including health IT makers and health IT buyers such as hospitals) - and the IT service providers themselves - need to really, really get their houses in order.

They need to stop beta-testing buggy software upon their customers (or live patients in the case of clinical IT).

Problems like this reflect significant and trust-busting incompetence, at best.

-- SS

Saturday, August 6, 2016

NIST workshop "The Role of Standards in Preventing & Mitigating Health IT Patient Safety Risks" perhaps should be titled "The Role of Common Sense in Preventing & Mitigating Health IT Patient Safety Risks Before Rolling Out Bad Health IT Nationally"

Ready, fire, aim.

As I wrote in 2010-12 at "Cart before the horse" posts at http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html and http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html, rolling out health IT nationally before having a firm grasp of its risks was an abrogation of medical ethics and long standing treatises on medical experimentation, including the need for informed consent, dating back to the post-WW2 period.

Ready, fire, aim:  let's roll out health IT nationally, then figure out how to make it safe...

Now we have this "workshop" to be held September 7, 2016:

http://www.nist.gov/healthcare/usability/the-role-of-standards-in-preventing-and-mitigating-health-it-patient-safety-risks-workshop.cfm

The Role of Standards in Preventing & Mitigating Health IT Patient Safety Risks

Purpose:
Health IT Community Technical Workshop for all Stakeholders: Learn and Share Industry Best Practices.

Objectives:
Bring together all Health IT stakeholders to share best practices and review the fundamentals of risk prevention and mitigation that apply to Health IT. Health IT standards are part of the foundation needed to deliver high quality, patient-centric care. The industry continues to gain a better understanding of the relationship between managing risk and providing quality care through the safe use of Health IT.

This forum is an opportunity to receive updates on the latest standards development process related to risk prevention and mitigation, quality assurance and safety-related usability, to find out about recent findings from studies conducted on this subject, and to bring industry stakeholders together to share best practice, and define the path forward for risk prevention and mitigation that apply to Health IT.

Agenda:
Final Agenda (http://www.nist.gov/healthcare/usability/upload/NIST-Workshop-Agenda-7_7_16.pdf)

This workshop is an admission that the industry lacked in understanding "of the relationship between managing risk and providing quality care through the safe use of Health IT" at a time when rollout of bad health IT was pushed like a Miracle Cure by government and industry pundits, and became a national mandate,

To all the boneheads who did push this technology out the door prematurely before its risks and safety were reasonably understood, and/or ignored the "iconoclasts" as they were derogatorily known, thanks for harassing doctors and nurses to the point of exhaustion, harming patients via cybernetic experimentation without consent, and wasting billions of dollars of taxpayer money.  (It would have been a very good thing, I note, if efforts like this had been mandated before my mother's demise of care continuity failure precipitated by bad health IT.)

NIST, this workshop is late, but better late than never.

However, I am increasingly of the belief that this technology is unsuitable for busy clinicians, as long as they bear the clerical burdens, and can never be fixed it that arrangement is not drastically changed.

"Best practices", I believe, call for a return to paper (specialized forms depending on the setting) for clinical data capture by busy doctors and nurses, and data entry into a computer via clerical personnel.

Why do I hold this belief?

I designed such a system for invasive cardiology (a highly complex, critical-care medical domain) 20 years ago that was highly successful and popular, even among busy invasive cardiologists, to replace a direct-computer-entry commercial product from hell.  This is written up at this link: http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story

After modeling the dataset for the domain of cardiac catheterization to a high degree of granularity, the forms were designed and tested collaboratively with the invasivist leaders, as seen below.

The physicians recorded real-time onto the forms, or shortly after they de-gloved.  There were also specialized forms for the cath lab technicians and nurses. Click to enlarge.  Each section could be supplemented via dictation if needed, and the text transcribed and sent to the application server for inclusion on the full cath report, via a direct link from central transcription.

No wasting of clinicians' valuable time and limited cognitive energy navigating lousy EHR user interfaces, interacting with a multitude of mind-numbing icons and widgets, and other frustrations looking to enter critical data.


Physician's data collection form, side 1.  Click to enlarge.
Physician's data collection form, side 2
Cath technician/nurse's data collection form, side 1
Cath technician/nurse's data collection form, side 2


Clerical employees were hired to perform data entry from the paper forms and inquire with the doctors when there were questions about data recorded during the cath.

Forms for less specialized medical domains would be significantly simpler.

Addendum:

Ca. 2007, (non-medical) Siemens Healthcare IT executives in Malvern, PA (a Siemens division now bought out by Cerner) were shown this project by me, still in use just a few miles south of them in Delaware, and deemed it "impractical" for commercialization.  I thought that very sadly ironic considering the incredible engineering prowess and accomplishments world-wide of parent company Siemens A.G.

In my direct first-hand experience, non-medical IT executives are one of the biggest impediments to health IT progress (and safety), in both hospitals and the pharmaceutical industry.

http://www.siemens.com/about/en/
About Siemens
Siemens is a global powerhouse focusing on the areas of electrification, automation and digitalization. One of the world’s largest producers of energy-efficient, resource-saving technologies, Siemens is a leading supplier of systems for power generation and transmission as well as medical diagnosis. In infrastructure and industry solutions the company plays a pioneering role. As of September 30, 2015, we had around 348,000 employees in more than 200 countries. In fiscal 2015, they generated revenues of €75.6 billion.

-- SS

Thursday, August 4, 2016

A Tenet of Impunity - Tenet Settles Kickback Allegations for $514 Million, No Individual Suffers Any Negative Consequences

Tramp, tramp, tramp.  The march of legal settlements continues.  The latest entry is a corporation that has had a 20 plus year history of legal misadventures, allegations of unethical behavior, and actual crimes.  Here are the basics from the Atlanta Business Chronicle:

Tenet Healthcare Corp. (NYSE: THC) said Monday that it believes it has reached an agreement in principle with the government to resolve a long-running criminal investigation and civil litigation about a kick-back scandal involving an Atlanta medical clinic and three of the company's Atlanta-area hospitals.

Dallas-based Tenet said it has agreed to pay $514 million, has agreed to the appointment by the U.S. Department of Justice of a corporate monitor for a period of three years, and has agreed for two wholly owned subsidiaries that previously operated Atlanta Medical Center and North Fulton Hospital to each plead guilty to a single-count indictment.

In particular, regarding kickbacks,

The company's two subsidiaries will plead guilty to a single count of conspiracy to violate the federal anti-kickback statute and defraud the United States, Tenet reported.

Four hospitals owned by Tenet -- Atlanta Medical Center, North Fulton Hospital, Spalding Regional Medical Center and Hilton Head Hospital -- allegedly paid kickbacks to a Georgia company called Clinica de la Mama for Medicaid patient referrals. Clinica de la Mama operated medical clinics that provided prenatal care to predominantly undocumented Hispanic women in metro Atlanta and Hilton Head, S.C.

The contracts were in effect for various periods from 2000 to 2013 between the four hospitals.

Like many such settlements, this one evoked almost no media coverage, and what coverage there was appeared in the business, not health care news.  For example, the brief Wall Street Journal story focused almost entirely on the financial implications for Tenet of the settlement.  Thus the anechoic effect continues.  

Unpacking the Settlement

Bad Patient Care

First of all, the settlement included guilty pleas to charges of "conspiracy to violate the federal anti-kickback strategy."  The allegations were that the kickbacks were paid "for Medicaid patient referrals."  That means that Tenet was alleged to have paid the operator of medical clinics to send patients to Tenet hospitals.  This goes beyond financial crime.

Physicians swear oathes to put the care of individual patients ahead of all other concerns.  The new American Medical Association Principles of Medical Ethics states:

A physician shall, while caring for a patient, regard responsibility to the patient as paramount.

That means that decisions by physicians to refer patients to specific hospitals, specialists, etc should be based on what referrals would be best for individual patients, and certainly not on payments to the physicians by such hospitals, specialists, etc.  Kickbacks like those described above could send patients to hospitals that were not the most suitable for the patients' needs, thus potentially harming patients.  So this case raises big concerns about bad patient care, not merely unethical money transfers.

Yet in the minimal media coverage of the Tenet settlement, I see nothing about medical ethics, potential harms to patients, etc. 

Impunity

As is typical of such settlements, no individual who might have authorized, directed or implemented the kickbacks suffered any consequences.  While top managers of Tenet might have gotten even bigger bonuses because of the additional revenues supplied by the sorts of behavior discussed above, they  would suffer no financial penalties as a result of this settlement.  In fact, in 2015, the current Tenet CEO,  Mr. Trevor Fetter, who was an officer of the company in 2013, the last year kickbacks covered by the settlement ocurred, received total compensation of $15,354,283 according to the company's 2016 proxy statement.

Although in this settlement there were at least some corporate guilty pleas, allowing this case to be considered criminal, these pleas were not made by Tenet.  Instead they were by its subisidiaries.  This would allow Tenet itself  to avoid any non-financial penalties, such as being barred from participating in US government programs.  While the monetary size of the settlement appeared to be large, it was trivial compared to Tenet's annual earnings, which last year were over $18.6 billion according to Google Finance.

This settlement, like many others, included a corporate integrity agreement.  Such agreements, and conceptually similar deferred prosecution agreements, were heavily promoted, in part through the use of a logical fallacy, by then US Attorney, now Governor of New Jersey Chris Christie.  However, there seems to be little evidence that they deter future bad behavior (look here).  

Recidivism

Tenet actually has a long, dark record of misbehavior.  In 2012, we published our last post on Tenet.  It was about a $42.7 million dollar settlement the company made then of charges it overbilled the Medicare program from 2005-07.  As we wrote then:

While this story appeared briefly and without context in a few business news outlet, it really is part of a much bigger picture.

National Medical Enterprises

Published in 2006, Maggie Mahar's Money Driven Medicine was one of the important early works on health care dysfunction (see post here, the web-site of the documentary film based on it here).  One of the striking cases it discussed was that of Nartional Medical Enterprises.  NME was charged not only with run of the mill offenses like over-billing, but more exotic ones like kidnapping patients. NME eventually settled with federal authorities in 1994 for $379 million, and pleaded guilty to a variety of charges. The results were similar to many more recent cases. No one went to jail, and the CEO walked away with a golden parachute.  Despite the seriousness of the offenses, NME did not go out of business.  It simply changed its name - to Tenet Healthcare.

Legal Problems in the 21st Century

The "new" Tenet continued to have legal issues.  These included a $395 million settlement of the Redding Medical Center unnecessary heart surgery scandal in 2004 (look here), and a $21 million settlement of US government charges of kickbacks (look here), a $7 million settlement with the government of Florida of charges of fraudulent billing (look here), and a $900 million settlement of federal over-billing complaints (look here, and see our post here), all in 2006.  There was an apparent lull, and then in 2011 the company settled a class action suit brought after the deaths of 34 patients in a Tenet facility in New Orleans after Hurricane Katrina (see Bloomberg story here.)

Yet this more than 20 year history of repeated allegations, settlements, and crime did not apparently affect the latest settlement.

Conclusions

Nearly every big US health care corporation now seems to now have a long history of bad behavior, sometimes criminal behavior, that has not stopped the revenues from flowing, and the top managers from becoming millionaires, or billionaires.  Is it any wonder that a few years ago, nearly a majority of US respondents to a Transparency International poll declared our health care system to tbe corrupt (look here)?

Their dark musings may be partially due to their awareness that health care corruption is a taboo topic.  As we wrote about it in 2016 (look here)...

 Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure.  In the Transparency International 2016 Report on health care corruption in the pharmaceutical industry,


However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks.  It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.

I might as well repeat myself once again.  As I wrote in 2015,

If we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.



Wednesday, July 27, 2016

The Wages of Sin - a Small Illustration of How Executives Can Personally Profit from Bad Corporate Behavior in Health Care

The resolution of two related cases involving drug/ biotechnology/ device giant Johnson and Johnson opened a small window on the perverse incentives driving bad managerial behavior in health care.

The Settlement of the Allegedly Illegal Marketing of the Stratus Device

The basics of the case, which looks like a typical marcher in the march of legal settlements, were best explained by Ed Silverman in Stat on July 22, 2016,

A Johnson & Johnson subsidiary has agreed to pay $18 million to resolve charges of causing health care providers to submit false claims to Medicare and other federal health care programs, which then paid for a device that was illegally marketed.

In particular,

In 2006, Acclarent won FDA approval to market its Stratus device to be used only with saline to maintain sinus openings following surgery. But the feds alleged the company intended to market Stratus as a drug-delivery device for prescription corticosteroids and maintained the device was specifically designed and engineered for this use, according to court documents.

Note that as is usual, the settlement involved a monetary penalty that would not even be spare change to Johnson and Johnson, which last year had total revenues of more than $70 billion according to Google Finance.  As is additionally usual, the settlement did not seem to be informed by Johnson and Johnson's huge record of previous settlements and other legal actions suggesting its misbehavior (see a list of these in the appendix below.)  As is also usual, the settlement involved no admissions of guilty or innocence by Johnson and Johnson itself, but as is further usual, a company public relations person said it was a long time ago, we have changed, and we will just move on.  As the Wall Street Journal reported,

A spokeswoman for Johnson & Johnson said the company has since put in place tighter compliance controls. She noted the agreement, which didn’t include an admission of liability or wrongdoing, resolves alleged conduct that took place almost entirely before Johnson & Johnson acquired Acclarent.

Two Johnson and Johnson Executives Convicted of Distributing Misbranded and Adulterated Devices

But one part of this case was unusual.  Not only did US government authorities pursue a settlement with Johnson and Johnson, they prosecuted two executives who were involved in setting up the bad behavior alleged in the settlement.  Per Mr Silverman in Stat,

The settlement with the US Department of Justice, which was disclosed on Friday, comes just two days after a pair of former executives at the J&J subsidiary, which is known as Acclarent, were found guilty of several misdemeanor charges of distributing a misbranded and adulterated device. A federal court jury in Boston found the executives marketed the Stratus device for a use that was not approved by the US Food and Drug Administration.

So while the Johnson and Johnson spokesperson denied that the company was guilty of anything, it appears that two people who eventually became Johnson and Johnson executives were found guilty of having a company that Johnson and Johnson acquired distribute a misbranded and adulterated device.  At best, the spokesperson seemed to be asserting a distinction in the absence of a meaningful difference.      

Especially, since the allegations that led to the convictions of the executives included actions that occurred after their company was acquired by Johnson and Johnson, per the Stat article,

Between 2008 and 2011, the men allegedly concealed a scheme to illegally distribute and promote a device they planned to market for delivering steroids to sinuses. The feds charged, however, they deceived the FDA by falsely claiming the intended use was to maintain an opening to the sinus, and that the device was supposed to be used with saline.

Acclarent, where Facteau was the chief executive and Fabian was the vice president of sales, was eventually sold to Johnson & Johnson in January 2010 for $785 million. Following the acquisition, Acclarent management was told to stop marketing the device for unapproved uses, but they continued to do so anyway, court documents stated.

So why would Mr Facteau and Fabian do this?  An article in Reuters implies an answer:

Prosecutors said Facteau and Fabian had hoped to increase the company's revenue to make it an attractive acquisition target, and concealed the off-label marketing from potential buyers, including J&J unit Ethicon Inc.

Ethicon bought California-based Acclarent in early 2010 for about $785 million. Facteau and Fabian received compensation worth about $30 million and $4 million, respectively, from the deal, according to the indictment.

So the former Acclarent executives, later Johnson and Johnson subsidiary, made what seems to be a lot of money from directing their company to distribute a misbranded and adulterated product.  In fact, they made considerably more money than Johnson and Johnson paid to settle the case.

Conclusions

So this case appears to be a step forward, in that not all the people who apparently authorized, directed, or implemented the bad behavior could escape any negative consequences.  Keep in mind, however, that no one above the two convicted executives, no one at Johnson and Johnson who decided to acquire Acclarent, and let it continue its previous activities, seemed to suffer any negative consequences.  How much money those executives might have received in response to the revenues that the new subsidiary brought in is unknown.

In conclusion, this case shows the perverse incentives at work that drive bad behavior by health care oragnizational leaders.  One can obviously become very rich by directing this bad behavior.  Up to now, the likelihood that one would eventually pay any penalty for doing so was tiny.  Now it is slightly higher.  Whether those up the ladder, who might have authorized the behavior, turned a blind eye to it, or avoided enquiring about anything that could be bad behavior, as long as the money came in, will suffer any negative consequences from these actions or inactions in the future is still unclear.

We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it.  True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why.  But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position.  It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public. 

Appendix - Johnson and Johnson Legal Record since 2010-
2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
2011
- Guilty pleas to bribery in Europe  by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
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).
-  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
2013
-  Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
 -  Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
- Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
- Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
2014 
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post). 
2015
-  Johnson & Johnson found by jury to have concealed harms of Risperdal.
-  Johnson & Johnson Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
-  Johnson & Johnson McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)

Thursday, July 21, 2016

Law and Order? - Bristol-Myers-Squibb Settles Case Alleging Fraud and Kickbacks, No Admissions of Guilt, No Individuals Charged

Introduction 

Donald Trump, Republican candidate for the US presidency last week announced he is the "law and order" candidate, accompanied by then vice presidential contender and New Jersey Governor Chris Christie.



I wonder if all this interest in law and order will lead to increasing the effectiveness of enforcing laws when large US health care corporations are accused?

For years, we have been watching a parade of legal settlements made by big US health care organizations.  These have included the biggest drug companies, biotechnology companies, device companies, insurance companies, etc, etc.  Many involved accusations of fraud, kickbacks, and other seeming crimes.

In many cases, the alleged white collar crimes could have resulted in harms to patients.  For example giving physicians kickbacks to promote particular drugs or devices could have led them to prescribe treatments that could have been useless for particular patients, yet subjected those patients to risks of adverse effects.

Yet few of these cases were resolved with findings of guilt.  Many resulted in financial penalties for the accused organization, but which were tiny compared to that organization's revenue.  Almost none resulted in any consequences for the people in the organization who might have individually profited from the alleged actions, particularly the top executives who were making millions of bonuses, suggesting their apparent impunity.

This parade of settlements does not look like instantiation of law and order to me, in my humble opinion.

Bristol-Myers-Squibb Settles Allegations of Kickbacks

And the parade continues.  The latest case, which barely was noticed in the media, involved huge pharmaceutical company Bristol-Myers-Squibb.  It was best documented by Ed Silverman in Stat,

After nearly a decade of litigation, Bristol-Myers Squibb on Monday agreed to pay $30 million to settle charges by California officials of paying kickbacks to induce doctors to prescribe several of its medicines.

The settlement with the California Department of Insurance stemmed from a whistleblower lawsuit that was filed in 2007 by three former Bristol-Myers employees. They alleged that from 1997 through 2003, the drug maker used a wide variety of inducements to generate revenue. The state later joined the lawsuit in 2011 and, last year, the former employees were dismissed from the case by a state court.

The kickbacks included box seats at sporting events where doctors were given food, drinks, and parking; enrollment in a Los Angeles Lakers basketball camp for doctors and their children; prepaid golf outings at luxury courses; tickets for doctors and their families to see Broadway shows in California cities; and lavish dinners, resort hotel trips, and concert tickets for doctors who were especially big prescribers.

Among the many medicines for which doctors were persuaded to write more prescriptions were the Pravachol cholesterol pill; the Plavix blood thinner; the Abilify antipsychotic; the Glucophage diabetes treatment; and the BuSpar antianxiety drug.

A Bristol-Myers spokesman wrote us that the company denied any wrongdoing, but also noted that the firm began adhering to a voluntary industry marketing code in 2002. 'We are pleased to put this matter behind us so that we can focus on making transformational medicines for patients battling serious diseases,' he wrote.

Note that in this case, as is typical for such cases, the financial penalty seems to be minimal compared to the company's total revenues (more than $16.5 billion according to Google finance.)  The company was allowed to deny wrongdoing (although in absence of same, why should it pay a fine?)  No individuals who might have personally profited from the actions in question suffered any negative consequences.

Why Not More Severe Penalties for a Repeat Offender?

Furthermore, the outcome seems to have nothing to do with the accused's track record.  Anyone who follows the news knows that in general, penalties in criminal cases are likely to be different for first offenders and habitual criminals.  Penalties in civil cases also may depend on the defendant's track record.

However, this case, like most other cases involving big health care organizations, seems to have occurred in a vacuum, separate from the company's track record.  Yet a bit of searching reveals that BMS, like many other big health care corporations, seems to have a pretty bad record.


- In 2003, for $617 million, BMS settled suits alleging it tried to prevent competition from low cost generic versions of its products Taxol and Buspar (per the NY Times).
- In 2004, for $150 million, BMS settled suits by the SEC alleging accounting fraud (per the NY Times here).
- In 2007, BMS paid a $1 million dollar penalty while pleading guilty to lying to federal agents about a deal with the Canadian drug company Apotex (per Law360).   In 2009, it paid additional financial penalties in response to a US Federal Trade Commission charge about this case (per the FTC).
 - In 2007, for $515 million, BMS settled a suit alleging it used kickbacks to induce use of Abilify for dementia and by childeren, despite evidence that the drug was not suitable for either.  The settlement included a five year corporate integrity agreement.  (Look at our post here).
 - In 2014, BMS settled allegations its subsidiary Lantheus Medical Imaging Inc evaded state taxes (per the Corporate Crime Reporter)
 - In 2015, Bristol-Myers-Squibb settled allegations by the US Securities and Exchange Commission (SEC) that it bribed physicians in China to induce them to prescribe its drugs.  (Look at our post here).

(Parenthetically, I apologize that many of these previous cases have not been previously mentioned on Health Care Renewal.  For that I apologize.  Yet some simple Google searches were all that were required to find them.)

Why did none of the law enforcers involved in the later cases do similar searches, and why did the company's track record not figure into how the current case was resolved?

Chris Christie and the Rise of the Deferred Prosecution or Corporate Integrity Agreement for Too Big to Jail Organizations

The answer to that will not be easy.  At best, it now seems to be standard operating procedure for law enforcement to treat big health care organizations very gently.  However, there is one clue in BMS track record that it might be helpful to discuss in this political season.


Note that in one of the biggest settlements listed above, BMS agreed to a corporate integrity agreement.  According to a 2015 article in Time, the use of such agreements, coupled with apparently large fines but no other penalties, for corporate offenders was pioneered by none other than then US Attorney Chris Christie, (who spoke in the video above).

Christie was apparently horrifed by the criminal prosecution of Arthur Andersen, a big accounting firm, in the wake of the Enron scandal.  At that time, federal prosecutors acted so that

The company itself—not its employees who might have been responsible—was indicted and found guilty. The trial put the company out of business. The conviction was overturned on appeal, but not before the company’s reputation was destroyed and its employees forever branded with a Scarlet Letter, representing Andersen, not Adultery.

The article described Mr Christie's response:

Christie had watched wall-to-wall coverage of the case, and it made him uncomfortable. He decided he did not want to run his office in that way. Instead of bulldozing New Jersey companies facing smaller-scale fraud cases and leaving their employees out of work, Christie preferred to build a case against the firms and then bring their leaders in for a take-it-or-leave-it chat. Ultimately, seven New Jersey corporations accepted deferred prosecution agreements, or deals with the government that let them avoid trial in exchange for the companies hiring independent monitors to oversee operations and put in place guards against future wrongdoing.

Christie often was relieved they were open to the deals. 'Put the company itself out of business? Lose all the jobs?' Christie asked when asked about the alternatives. He pointed to a corruption case he built against St. Barnabas Health Care System, the state’s largest, for double- and over-billing Medicare and Medicaid services. St. Barnabas paid $265 million to settle the case. 'What are you going to do?' Christie asks. 'Close the hospital, the largest hospital that serves the poor?'

Neither Time, nor Mr Christie seemed to notice that this reasoning involved a logical fallacy, a false dilemma.  True, there are two options:
1) criminally prosecute the whole company
2) allow the company to operate under a deferred prosecution or corporate integrity agreement.
But there is a third option:
3) Criminally prosecute the individuals in the company who were most involved in and most benefited from the bad behavior.

So in the St Barnabas example, what he could have done was prosecute the people at St Barnabas who were most responsible for the over-billing, and let the hospital itself go with a fine. Mr Christie for some reason never seemed to think about that option.  Neither have most other US law enforcers who have dealt with large organizations since.

Ironically, Mr Christie has got himself into some ethical hot water because of how he managed corporate integrity or deferred prosecution agreements involving BMS and other health care organizations.  Some have alleged that Mr Christie found some other advantages to using such agreements, advantages that accrued mainly to Mr Christie and his cronies.  As the Time article noted, re BMS

As part of its penance, the company also proposed paying for a professor of business ethics at a law school. The company initially offered to pick up the tab at a school in New York. No way, Christie said. 'This is a New Jersey case. Pick a New Jersey school,' Christie replied. Rutgers already had such a program, and there was only one other law school in New Jersey. It just happened to be Christie’s alma mater, Seton Hall. 'It couldn’t have mattered less to me,' Christie says. 'I didn’t get anything out of it. I was long graduated from Seton Hall.' (The Justice Department signed off on the agreement, but would later limit U.S. Attorneys’ ability to negotiate such deals.)

Christie’s critics pounced on the $5 million payment to Seton Hall, and to this day are trying to use it as a way to suggest he is another pay-to-play New Jersey politician.

And in two other health care cases:

Christie hired former Attorney General John Ashcroft, his one-time boss, to monitor Zimmer Inc., one of the firms that settled with the government. In turn, Ashcroft’s company charged between $1.5 million and $2.9 million a month to monitor the medical device company. By the time Christie arrived in Washington to answer lawmakers’ questions, The Ashcroft Group had earned $52 million on that case. 'To me, that is outrageous,' Rep. Steve Cohen chided Christie. 'I don’t care what you did. It is not worth $52 million,' the Tennessee Democrat continued. 'Even if you took steroids and hit 70 home runs, it is not worth $52 million.'

Lawmakers also wanted to know why he named David Kelley to a post to oversee the Bristol-Myers Squibb settlement. Kelley two years earlier, as a former prosecutor, declined to bring securities fraud charges against Todd Christie, the future-Governor’s brother. Was this payback for sparing a Christie Family?

Mr Christie defended his conduct in the BMS case:

Christie to this day says he has no regrets about the deferred prosecution agreements, including the professor position. To him, it matters less about whether there was a conviction than whether the illegal behavior ended. 'The goal as the U.S. Attorney is to stop the conduct,' Christie says. 'If you’ve stopped the conduct, you’ve won.'

But of course the current case, and those involving BMS from 2014 and 2015, shows that Mr Christie's corporate integrity agreement did not "stop the conduct" at least in the case of BMS.  That rationale was fallacious too.


Summary

Now that political campaigners are once again shouting about law and order, maybe this is the time to call for effective and equal enforcement of the laws regarding white collar crime in health care.  For years, we have watched perpetrators of small scale Medicaid and Medicare fraud go to jail.  Yet when big companies are accused of big scale crime, almost no one ever goes to jail.

It is time for equal justice for all in health care.

Let me end with a quote from a report by Senator Elizabeth Warren (D - Massachusetts) published in January, 2016, entitled "Rigged Justice: 2016 - How Weak Enforcement Lets Corporate Offenders Off Easy."

 Laws are effective only to the extent they are enforced. A law on the books has little impact if prosecution is highly unlikely.

This country devotes substantial resources to the prosecution of crimes such as murder, assault, kidnapping, burglary and theft, both in an effort to deter future criminal activity and to provide victims with some degree of justice. Strong enforcement of corporate criminal laws serves similar goals: to deter future criminal activity by making would-be lawbreakers think twice before breaking the law and, sometimes, by helping victims recover from their injuries.

When government regulators and prosecutors fail to pursue big corporations or their executives who violate the law, or when the government lets them off with a slap on the wrist, corporate criminals have free rein to operate outside the law. They can game the system, cheat families, rip off taxpayers, and even take actions that result in the death of innocent victims—all with no serious consequences.

The failure to punish big corporations or their executives when they break the law undermines the foundations of this great country: If justice means a prison sentence for a teenager who steals a car, but it means nothing more than a sideways glance at a CEO who quietly engineers the theft of billions of dollars, then the promise of equal justice under the law has turned into a lie. The failure to prosecute big, visible crimes has a corrosive effect on the fabric of democracy and our shared belief that we are all equal in the eyes of the law.

Under the current approach to enforcement, corporate criminals routinely escape meaningful prosecution for their misconduct. This is so despite the fact that the law is unambiguous: if a corporation has violated the law, individuals within the corporation must also have violated the law. If the corporation is subject to charges of wrongdoing, so are those in the corporation who planned, authorized or took the actions. But even in cases of flagrant corporate law breaking, federal law enforcement agencies – and particularly the Department of Justice (DOJ) – rarely seek prosecution of individuals. In fact, federal agencies rarely pursue convictions of either large corporations or their executives in a court of law. Instead, they agree to criminal and civil settlements with corporations that rarely require any admission of wrongdoing and they let the executives go free without any individual accountability.

And end with a video of her speaking on the subject.




Tuesday, July 19, 2016

UnitedHealth's Optum Division Settles Case Alleging it Enrolled Non-Terminally Ill Patients in Hospice, Thus Risking Their Deaths Due to Treatable Illnesses

Fraudulant hospice enrollment is a uniquely dangerous practice, yet the latest cases of it have, as usual, attracted little attention.

Background

As we have discussed before, hospice care was initially designed to provide more humane treatment of the terminally ill, particularly patients with advanced cancer.  The idea was that rather than subjecting such patients to futile, but often painful or dangerous treatment, they would receive humane, palliative care.  Hospice care initally was provided in the US by small, local non-profit organizations.  But since Medicare pays for hospice care fairly well, for-profit corporations soon got into the act.  As we have discussed previously, some hospices, often but not always for-profit, began to admit patients who were not terminally ill.

The danger is that hospice care specifically excludes potentially curative care, such as antibiotics for infection or surgery for appendicitis.  So if a patient who is not terminal is in hospice and that patient develops severe bacterial pneumonia, that patient may not get antibiotics and thus may die of a potentially curable disease. 

We have been writing about this dangerous aspect of modern hospice care since 2011 (look here).  In various posts here we have detailed particular cases of non-terminal patients admitted to hospice who later died, seemingly of the neglect of treatable illness mandated by the concept of hospice care.  There have also been cases in which patients with chronic pain, but no terminal illness, may have died from hospice's overly aggressive use of narcotics .  For example, in a 2014 Wasthington Post story,

Clinard 'Bud' Coffey, 77, a retired corrections officer, did the crossword in The Charlotte Observer after breakfast every morning, pursued his hobby of drawing cartoons, talked seven or eight times a day to his son Jeff and, just two weeks before his death, told a pal that he still felt 'like a teenager.'

He did, however, have some chronic back pain, and in late March he was enrolled in hospice care 'essentially for pain management,' his doctor said. Over a two week period, he received rising doses of morphine and other powerful drugs, grew sleepy and disoriented, and stopped breathing, dying peacefully at home, according to his family and medical records they provided.

The Latest UnitedHealth/ Optum Case

The latest case of allegations of fraudulant hospice enrollment involved a very big, very profitable corporation.  As reported in detail only in the Minneapolis Star-Tribune,

A division at Minnetonka-based UnitedHealth Group is paying $18 million to settle allegations that it submitted false claims to Medicare for hospice patients who were not terminally ill.

The payment announced this week resolves a whistleblower lawsuit against Optum Palliative and Hospice Care that alleged the company tried to boost the number of patients for whom it could bill the federal Medicare program, without regard to whether they were eligible for and needed hospice services.

UnitedHealth Group's Optum subsidiary is a fairly big player in the commercial hospice world,

Optum/Evercare provides hospice care in 12 U.S. markets, including Arizona and Colorado. It does not operate in Minnesota.

The Strib provides a bit more detail about what seems to have happened.

The government alleged that false claims in the case were submitted to Medicare from Jan. 1, 2007, through Dec. 31, 2013. The lawsuit argued that Optum discouraged doctors from recommending that ineligible patients be discharged from hospice, and failed to ensure that nurses accurately and completely documented patients’ conditions.

The allegations were first raised by former employees in whistleblower lawsuits, which let private parties sue on behalf of the government and share in any recovery. The share to be awarded in the Optum case has not yet been determined, the Justice Department said in a news release.

As is now tediously typical in legal settlements involving large health care organizations, the government allowed the case to settle without any determination of guilt or innocence, and of course, without any individual who may have profited from the alleged bad behavior having to suffer any negative consequences.

'We are pleased to resolve this issue and are proud of our long record of providing high-quality, compassionate hospice care consistent with the needs of patients and supported by their doctors and family members,' Optum said in a statement. 'We believe Evercare Hospice acted properly and did not engage in wrongdoing.'

Also,

'The claims resolved by the settlement are allegations only, and there has been no determination of liability,' the Justice Department said in a news release.

As is also usual in these cases, the monetary value of the settlement, while it might appear large to a middle-class lay-person, is tiny compared to the revenue of UnitedHealth. For example, according to Google Finance, the corporation's 2015 total revenue exceeded $157 billion.

All that would be bad enough if the case only involved financial fraud.  Again, as noted above, it is possible that some patients without terminal disease who were enrolled in UnitedHealth's Optum hospice could have died of treatable conditions.  Yet this possiblility was not addressed by the limited press coverage of this case, or even by the US Department of Justice's news release about the settlement. 

Other Recent Cases

In 2016, there have been nearly anechoic media reports of cases of smaller hospices at least alleged to have deliberately enrolled non-terminal cases.  Perhaps because these organizations involved were not "too big to jail," some of these cases involved findings of guilt.

Home Care Hospice

In February, 2016, according to the Philadelphia Business Journal,

Nearly three years after fraud charges against a Philadelphia nurse first surfaced, a jury found 68-year-old Patricia McGill guilty for her role in scamming Medicare out of $9.32 million.

McGill was the director of professional services for Home Care Hospice for roughly three years beginning in 2005. During that time, she authorized and supervised the admission of patients for hospice services that they did not need or were not eligible for, according to court records.

This was not the first finding of guilt in this case involving a small, local for-profit hospice.

Alex Pugman and Matthew Kolodesh, the owners of the defunct Home Care Hospice – at one time located along Grant Avenue in Northeast Philly – were previously convicted for their part in the crime. Kolodesh, of Bucks County, was sentenced to 14 years in prison after being found guilty on more than 30 separate counts.

Note that the sentences were severe, but as far as I could tell, not based on the possible danger to patients without terminal illness created by their admission to hospice.

Horizon Hospice Subsidiairy of  JourneyCare

As reported by the Pittsburgh Post-Gazette in March, 2016,

The former top executive at Horizons Hospice in Monroeville is set to enter a guilty plea Friday in connection with charges of scheming to send patients to the center who weren’t terminal so she could bill Medicare and Medicaid.

She was not the first person to be found guilty in this case.

One of the key witnesses was expected to be Oliver Herndon of Peters, the medical director at Horizons from 2008 to 2012.

Herndon was sentenced in July to 33 months in prison after pleading guilty to certifying patients for hospice care who weren’t terminal and keeping them there longer so Horizons could continue billing the government.

Again, the possible danger to the fraudulantly enrolled patients was not discussed in the media accounts. Note that Horizons Hospice is a subsidiary of JourneyCare, which appears to be a non-profit organization.

Multiple Michigan Hospices

As reported in April, 2016, by the Washington Free Beacon,

Five individuals who have donated to Democratic politicians pleaded guilty to a scheme that drained Medicare out of $33 million dollars.

Two physicians and three owners of hospice and home care companies based out of Detroit, Mich., were charged on June 18, 2015 as part of the largest Medicare fraud case in history for submitting fraudulent claims for home health care and hospice services that were either not provided or deemed medically unnecessary.

The elaborate operation revolved around Muhammad Tariq, Shahid Tahir, and Manawar Javed—the owners of the home health care and hospice companies—paying kickbacks and bribes to physicians for referrals to their companies that included A Plus Hospice and Palliative Care, At Home Hospice, and At Home Network Inc.

While the reporting of this case focused on the apparent political leanings of the individuals involved, it also ignored any danger to non-terminal patients.


Discussion

The problem of fraudulant enrollment of non-terminal patients in hospice continues, despite our efforts over five years to make the problem more public.  The latest case involved a very big, very wealthy for-profit health care corporation which has had its share of troubles in the past.  Yet the latest case is as anechoic as earlier ones, including smaller cases this year.

These enrollments may be motivated by the desire for more money, but they put patients at risk.  Nonetheless, such abuses by hospices get little press coverage, seemingly are ignored by health care regulators and law enforcement, and are almost completely anechoic in the health care, medical and health policy literature.

If a measure of society is how it cares for the most vulnerable patients, the US laissez faire approach to for-profit hospices suggests a society in decline.

To repeat what I wrote the last time for-profit hospices were (barely) in the news for enrolling the wrong patients,...

 In my humble opinion, we should return control of direct patient care, especially of the most vulnerable patients, to health care professionals and if necessary small non-profit community organizations.  We ought to give strong consideration to banning corporate hospices, and banning all forms of the corporate practice of medicine and corporate health care "delivery."

Given how many insiders make so much money from the current version of laissez faire capitalism in health care, however, I would expect strong resistance should such apparently "radical," but actually conservative proposals actually get any mainstream attention.

But in an election season now often dominated by ridiculous hyperbole and outlandish statements, maybe such vitally (literally) important issues should start getting some attention.