InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

Radio station News 88.9 KNPR, the NPR affiliate in Las Vegas did a segment today on the following news story.  The station’s Senior Producer had invited me to participate via phone regarding patient privacy issues.


Emphases mine:

 

http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy

February 10, 2014 – Updated  February 11, 2014
Federal complaint alleges St. Rose Hospitals violated patient privacy

By STEVEN SLIVKA
LAS VEGAS REVIEW-JOURNAL

Dignity Health, the owner of St. Rose Dominican Hospitals, is facing a federal complaint alleging it violated patient privacy by using patient records as leverage in a contract dispute.
According to a Monday announcement from the Nevada Health Services Coalition, Dignity Health used patient records to contact those with coalition member plans after agreements between the two agencies fell through in January, something it contends violates the Health Insurance Portability and Accountability Act, or HIPAA. The complaint was filed with the U.S. Department of Health and Human Services Office of Civil Rights.

The complaint contends St. Rose contacted former patients in an attempt to persuade them to take action with their health plans favorable to St. Rose. The complaint also said that St. Rose claimed their actions were simply to be “informative.”

“It’s our position that patient data collected in the course of medical treatment should not be used to lobby or gain leverage in contract negotiations,” said Christine Carafelli, executive director of the coalition.

The Nevada Health Services Coalition is a nonprofit entity that negotiates hospital contracts for discounted health care service rates for 19 member group organizations, totaling approximately 230,000 Nevada residents.

A spokesperson for St. Rose said they would issue a statement on Tuesday. 

The segment has now completed.  It was hosted by Dave Becker of KNPR.

A representative of the Health Services Coalition (http://www.lvhsc.org/), a
local organization of union, casino and local government health funds
who bargain together for maximum
leverage, participated, as did a hospital VP. 

The coalition is accusing the St. Rose hospital group (a division of
Dignity Health) of using patient records to contact patients to urge
them to lobby for the hospital in contract negotiations.

I was asked for an opinion on the acceptability of access to patient information in an organization’s EHR systems (including PHI such as name, address and other contact information) for purposes of soliciting the patients to lobby the insurers on behalf of the healthcare organization for better terms.

My opinion was clear, which I summarize as follows:

1.  Hospitals do not “own” patient data to use as they please.  Is is not a simple business asset, like typewriters – or computers.  Any belief that a hospital can treat patient records as such, to be used as they pleased, would reflect arrogance;

2.  The HIPAA privacy rule and its exceptions (viewable at http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/, section under “Permitted Uses and Disclosures“) would preclude the use of patient’s private and protected information in an EHR for selective solicitation for lobbying on behalf of the hospital;

3.  Who accessed the patient information, and exactly what they accessed, is not clear, and an electronic audit trail needs to be disclosed as to these issues;

5.  The hospital could have accomplished such goals transparently, safely, and without access to private health information, by putting an ad on the radio (or newspaper etc.), or mailing a general newsletter such as I often receive from area hospitals, even hospitals where I was never a patient.

A hospital VP contributed soothing words that the hospital respects patient privacy, trusts its employees and doesn’t wish this matter to become a stumbling block in negotiations.  However, in my opinion the hospital violated the HIPAA privacy rules and potentially put patient privacy at risk. 

No
amount of soothing, deflecting executive language and shifting of the
discussion can change that, and a full disclosure accounting would be
proper. 

(I note the HIPAA privacy rules do not state “For informational purposes only.  Use patient information however you want if you trust your employees and you think the risk is low..“)

That is, assuming an audit trail of sufficient detail is recorded in their EHRs, assuming it is turned on, and assuming it can be trusted in light of the HHS OIG report of Dec. 2013 where many hospitals admitted EHR audit trails can be deleted or edited by a person with appropriate credentials.  (See my Dec. 10, 2013 post 44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they’d like” at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html).

The segment audio is online here: http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939

— SS 


Feb. 14, 2014 Addendum:

A thought experiment demonstrates just how far from propriety, in my opinion, this affair is:

If a hospital can use confidential information in this manner, to enlist patients as de facto lobbyists regarding an insurer, then why could not a hospital use other data – e.g., patients’ disease burden, smoking status or even sexual orientation to ask them to lobby, say, a politician to gain some advantage, such as certificate-of-need approval for expansion, or anti-competitive legislation?  Or, to ask patients to participate in political activities for/against some politician or group that might hold views or conduct activities favorable/unfavorable to the hospital’s interests?

— SS

New York – Presbyterian Hospital Trustee Advocated Novel Cardiac Procedure – "Reach In, Rip Out Their Heart, and Eat It Before They Die"

The dominant theme of Health Care Renewal has been how problems with the leadership of health care organizations have lead to our current state of health care dysfunction.  We have discussed examples of ill-informed, mission-hostile leadership rewarded with excess compensation, exhibiting impunity in the face of alleged misbehavior, and at times descending into corruption.  The cause of these problems is doubtless multi factorial.  However, one possible cause is that rather than exercise stewardship and hold leadership accountable, those in charge of governance of health care organizations, that is, boards of directors or trustees, have instead infected the organizations with the amoral culture now dominant in much of the business world, especially finance.  We have discussed, most recently here and here, how the boards of health care corporations often include heavy representation of leaders of finance, including many of those who seemed responsible for the global financial collapse, great recession, or whatever we will end up calling it. 

I recently stumbled upon a particularly graphic example of the sort of predatory culture that now exists on the boards of health care organizations.  (More on how I did so later.)  Below is an embedded YouTube video of a speech made by a current Trustee of New York – Presbyterian Hospital (who has been on the board since 2007).  He is Richard Fuld, the former CEO of Lehman Brothers, whose continuing role on the hospital board, despite his failed leadership of one of the financial firms whose bankruptcy ushered in the global financial collapse, we discussed first here.

Just to underline it once more, Mr Fuld, referring to short sellers of his company’s stock, said he “what I really want to do is I want to reach in, rip out their heart, and eat it before they die.” 

Can there be a more stark reminder of what has gone wrong with the governance of health care?  Can anyone watch this video and argue that Mr Fuld ought to be on the board of a hospital system?  Why is he still on the board in January, 2012, when this video was released in October, 2011?

While I suspect not many other hospital system board members have been videographed displaying equally brutal sentiments, there are likely others with similarly barbaric tendencies.

So, on a more positive note…. The boards of hospitals, hospital systems, medical schools, and their parent universities ought to be populated with people who take their stewardship roles seriously.  They ought to be people who understand, agree with, and support the organizations’ mission, and their dedication to patient care and teaching.  They ought to understand what good leadership of health care organizations entail.  Needless to say, they ought to be of good character and above any ethical reproach.  In short, they ought to be the opposite of the sort of person displayed in the video above.

It should now be obvious that grievous problems with the leadership and governance of health care organizations are principle causes of the dysfunction in our health care system.  True health care reform will require wholesale changes in health care leadership and governance.

PS – In case the video above seems too short on context, see the one below:

RUC Off – the New England Journal Once Again Fails to Mention the Unmentionable

Last week, the influential New England Journal of Medicine published an article by Bruce Vladek entitled “Fixing Medicare’s Physician Payment System.”(1)  Although only identified as working for Nexara, a health consulting business, Mr Vladek was a former administrator of what was then called the Health Care Financing Administration (HCFA) of the US Department of Health and Human Services (DHHS), the part of the department that then ran the US Medicare program.  Vladek thus can reasonably be viewed as an expert on Medicare. 

Vladek identified two main problems with the current way physicians are paid by Medicare.  First,

Medicare is captive to an arbitrary, if elegantly conceived, formula for total payments to physicians — the sustainable growth rate (SGR). In the alternate reality of the Congressional budget process, the SGR will reduce Medicare’s physician payments, which already trail those from private insurers, as far into the future as the eye can see.

Second,

there is widespread consensus that the relative fees in the current system are a significant cause of the growing imbalance in supply and utilization between primary care and specialty services in the U.S. health care system. That imbalance, in turn, is widely perceived as a major cause of both excessive costs and inadequate quality of care. This is not just a Medicare problem: the Medicare Resource-Based Relative Value Scale is used by most private insurers to set relative prices for physicians.

Vladek expanded on the second point as follows

the basic mechanics of the Medicare Physician Fee Schedule, which was supposed to change physician payment to increase rewards for primary care services at the expense of procedural and interventional services, appears to have gone totally off track. For various reasons, the fee schedule, which originally did increase the prices of evaluation and management services relative to those of surgery or invasive procedures, turned in the other direction through the process of annual updating of relative value units. Surgeons, radiologists, and some medical specialists are now paid two to three times as much per hour as providers of cognitive services, which is about where we began 20 years ago; this was the situation that the fee schedule was supposed to fix.

The question of the relative virtues of primary versus specialty care can be debated ad nauseam, but in other wealthy countries that serve their populations at least as well as we do, the ratio of primary care physicians to specialists is much higher than in the United States, and the gap in compensation is much smaller or the poles even reversed. Young physicians, burdened by increasing educational debts, may well choose a career path on the basis of a major difference in compensation, especially when the better-compensated positions require less ongoing responsibility for patients and offer better working hours.

This is about all that Vladek wrote about how the imbalance between how Medicare pays for primary care and other “cognitive services,” and for procedures came about. Vladek, and many others have argued that this imbalance has lead to strong financial incentives that have been slowly destroying primary care, and strong incentives that have lead to the use of too many procedures, both strong drivers of rising costs in the most expensive health care system in the world.

Vladek noted vaguely that “through various reasons,” the incentives were imbalanced by “the process of annual updating of relative value units.”

However, as we have discussed in several blog posts, a lot more is known about how this process got “totally off track.”

In fact, in 2007, an article by Bodenheimer et al in the Annals of Internal Medicine explained the problems in considerably more detail.(2)  As we wrote then, Its main points included

  • Proceduralists are often able to learn how to do their procedures more quickly, and thus increase the volume of procedures done, while office and hospital visits can only be sped up so much.
  • The process used to update the RBRVS system is biased towards procedures for three main reasons: 1. “specialty society influence in proposing RVU [relative value unit] increases,” 2. the specialist-heavy RUC [Relative Value Scale Update Committee] membership,” and 3. “the desire of RUC specialists to avoid increases in evaluation and management [that is, cognitive, or non-procedural] RVUs.”
  • Medicare now uses a formula to limit increases in overall spending. The use of this formula leads to across the board cuts in all reimbursements. Since cognitive services reimbursements were never high to begin with, and have rarely been individually increased, these cuts tend to have disproportionate decreases.
  • Private insurers and managed care organizations tend to follow Medicare’s lead in their reimbursement procedures, but tend to tilt the playing field even more in favor of procedures versus cognitive services. Several studies showed that such payers paid more for procedures than did Medicare, but about the same for office and hospital visits.

The role of the RBRVS Update Committee (RUC) is complex and in many ways mysterious.  As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an “expert panel” that takes advantage of the organization’s First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.

To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation.  Their names do not appear.  A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that “a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide.” This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it.  Thus, the RUC membership as at best relatively opaque.

To expand on the ultimate point, as Goodson(3) noted, RUC “meetings are closed to outside observers except by invitation of the chair.” Furthermore, he stated, “proceedings are proprietary and therefore not publicly available for review.”

The fog surrounding the operations of the RUC seems to have affected many who write about.  We have posted (here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC.  In 2010, post the US recent attempt at health care reform, the RUC seems to remain the great unmentionable.  Even the leading US medical journal seems reluctant to even print its name. 

Thus, as we noted before, however, the mysteries about it remain:

  • How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
  • Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
  • How did the RUC become de facto in charge of this process?
  • Why does the AMA keep the membership on the RUC so opaque, and give no input into the RUC process to its general membership?
  • Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
  • Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

Without discussing how the incentives for physicians became so unbalanced, do we really expect we can fix them?  In this case, the persistence of the anechoic effect seems to be doing real damage to the discussion of the critical issues we in the US face today.
References


1. Vladek B. Fixing Medicare’s physician payment system. N Engl J Med 2010; 362:1955-1957. (Link here.)
2. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.)
3. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310.  (Link here.)

“Consumer Choice” and Complexity

One of the conservative mantras in recent years has been “consumer choice.” When Medicare Part D and Medicare Advantage Plans were designed, the availability of a variety of not-strictly-comparable plans was held to be a benefit to “consumers.” The Federal Employees Health Benefits (FEHB) program of health insurance plans available to federal employees and retirees was held up as an example of how “empowering the consumer” made for good insurance coverage – with federal employees having flexibility to change plans annually during enrollment “open season.”

I’ve been federally insured since the early 1980s. I’ve had the commonest federal health coverage since 1993 (Blue Cross Blue Shield Standard has the most enrollees with over half of those insured). However, this year BCBS Standard plan changes made me decide fast that I now needed to change my insurer. Coverage of out-of-network providers had been lowered markedly with a $7500 deductible for out-of-network surgeons. Although I haven’t had surgery in 50 years, I’m well aware you never know what weird malady you might get or what specific skills you might need, so that was a deal-breaker. [Incidentally, later on Congress became aware of this change and was irked – rightly – that OPM had allowed it. The change gave BCBS even more leverage over surgeons’ prices and could cost patients a bundle. Subsequently, for the first time in history, the federal enrollment deadline was extended this year and some BCBS changes were made – no $7500 deductible – but out-of-network coverage is still lower than previously and having evaluated the options, I am not interested any more in BCBS.]

I quickly eliminated a large number of my options. I was only willing to consider a nationwide plan not local insurers or HMOs. But intelligently comparing just the nationwide plans available to me took MANY hours. The insurance brochures follow a somewhat standardized format to aid comparability, but they comprise hundreds of pages. Happily, DC-based Consumers’ Checkbook publishes a first-rate, very helpful booklet each open season on making the selection. Even with that help, understanding my options was tedious, time-consuming, and dizzyingly mind-bending. [Each plan has its widely varying gotchas. Some insurers don’t pay network rates to a non-network provider at an in-network facility even if no one else is available. Others don’t want to pay for assistant surgeons. Some have low ceilings on hospice spending. Plans state catastrophic limits on spending, but sometimes pharmaceutical costs count toward the limit, sometimes not. And on and on . . .]

I narrowed it down to a few plans and have made a reasonable choice that I expect and hope to be pleased with. But, it’s all so complicated I’m still not certain that in the right (wrong) circumstances I might not have missed a gotcha. However, I believe I have chosen pretty well.

This year, comparing plans was a job that I (with an academic background, good health, and time) was willing and able to do. Realistically, most people are not able to evaluate sensibly such complicated options. I suspect most federal enrollees stayed with BCBS Standard this year even though with the changes they’d be better off in other available plans. I’m grateful I had time this year to do the work involved. Last year, I thought I probably should look at changing because of some other plan considerations. But I had a stressful and demanding job situation at that time, so I simply could not – and did not – do so. Most people are neither willing nor able to take the time to thoroughly read hundreds of pages and evaluate detailed options. So, they either rely on inertia (as I did last year) or they choose on something absolutely stupid – like the amount of the co-pay when they have a routine doctor visit.

Medicare Part D and Medicare Advantage plans put a similar burden on people. The old, ailing, or disabled are even less likely to be able to compare disparate, complicated plans. In the fictional ”consumer choice” fantasy world where everyone did take the time to choose intelligently, the aggregate time burden would be enormous. Here in the real world, most people don’t (and often realistically can’t) choose on the basis of considerations most material to them. They discover the adequacy of this year’s plan only if and when it ends up causing them problems – then they change in a subsequent year. Meantime, they may have incurred debt or been unable to meet medical needs. Most people are healthy. When plans are judged by last year’s experience, plans can keep most enrollees despite coverage gaps, because enrollees won’t uncover problems till they get sick (when plans are not sorry to have them switch away).

Although I’m happy to be in FEHB, I don’t think “consumer choice” is what has made FEHB better than much other health insurance. I think what has historically ensured its value is that federal provision of employee health benefits is fairly generous and that the Office of Personnel Management has looked out for federal workers. With OPM keeping a close eye, almost any plan selected has been a pretty decent choice (they fell down in their responsibility this year on the BCBS contract – the lame explanation of an OPM spokesperson can be found here. But FEHB is not, despite numerous claims, an advertisement for “consumer choice.” Consumer choice simply doesn’t have a chance of being a guarantor of quality without controlled, standardized, comparable policies.

Another Death in a Gene Therapy Trial

The case of the death of a research subject in an early trial of gene therapy for arthritis raises some eerie parallels to previous cases. So far the case has sparked minimal media attention, so although the news so far raises far more questions than answers, it appears worth summarizing on Health Care Renewal.

As reported by the Seattle Times,

Shortly after suspending a major clinical trial because of serious illness in a patient, Targeted Genetics and federal regulators said Thursday that the person had died.

Whether it was the experimental arthritis drug being tested that caused the illness is not yet known. But the condition ‘was related in time to the receipt of a second injection of the product,’ the U.S. Food and Drug Administration said Thursday in a statement. The agency is investigating whether the illness was related to the treatment.

‘We do not yet understand the cause of death,’ said Barrie Carter, Targeted Genetics’ chief scientific officer.

Some 127 patients have received an initial dose of the active drug or placebo, including 74 that received a second dose of the drug, Targeted Genetics said. The drug, known as tgAAC94, is designed to be used along with other therapies.

The Scientist provided a little more detail about the therapeutic intervention.

Researchers in the field say the treatment’s delivery vector, an adeno-associated virus (AAV), was unlikely to be the culprit.

‘Vectors in this class have been used on hundreds of patients over the last 12 years, and are not associated with acute toxicity,’ said Terence Flotte of the University of Massachusetts Medical School in Worcester. Flotte has been a principal investigator in several clinical trials of AAV-based gene therapy, but is not associated with the trial in question. ‘I’ve never seen anything like this,’ he told The Scientist. ‘Whatever this is, it’s unusual.’

In the trial, the AAV vector delivered a transgene encoding the receptor for tumor necrosis factor (TNF)-alpha, a cytokine that causes joint swelling in arthritis patients. The receptor, secreted by the target cells, binds to TNF-alpha, to reduce inflammation and protect the joint.

Usually prescribed for autoimmune conditions such as rheumatoid arthritis, the TNF-alpha receptor works by suppressing the immune system. But the protein could also have opened the door to an infection, suggested Flotte.

The Washington Post reported that a US National Institutes of Health (NIH) panel that reviewed the initial project protocol had some serious doubts.

Unlike the vast majority of such proposals, all of which aim to treat diseases by giving patients new genes, the plan to inject trillions of genetically engineered viruses into the joints of patients with arthritis was flagged for a special public review by the federal Recombinant DNA Advisory Committee, part of the National Institutes of Health.

At that Sept. 17, 2003, meeting, representatives of the sponsoring company, Targeted Genetics Corp. of Seattle, listened as a panel of experts wondered aloud why such a novel and possibly risky approach was to be offered to patients who were not especially ill, including some who had not even tried standard treatments.

Reviewers questioned the justification for the study, given that animal studies had found only a ‘limited correlation’ between the treatment and any improvements in subjects’ condition. And they asked for more assurance that the engineered viruses were not going to spread around the body or cause untoward immune system reactions in patients.

Some also expressed concern that the informed consent document the researchers planned to use to describe the risks and benefits to participating patients was not upfront enough about the fact that the study was unlikely to help them and was designed merely to test the new approach’s safety.

Even more eerie was the study’s ties to a previous failed study of gene therapy. Per the Seattle Times,

The death is the second in the history of gene-therapy trials, experts said. In 1999, 18-year old Jesse Gelsinger, part of a University of Pennsylvania study on an inherited liver disease, died of a massive immune reaction to a gene-therapy treatment.

There’s a business link to Targeted Genetics from that case: The UPenn experiment was led by Dr. James Wilson, whose company, Genovo, licensed the technology used in the trial. Targeted Genetics acquired Genovo in 2000 for $66 million in stock.

The company, however, says that there’s no Genovo technology in its inflammatory-arthritis drug.

Note further that Wilson, who owned 30% of Genovo stock, reportedly made $13.5 million from the sale of the company to Targeted Genetics, per an article in the Seattle Times “Uninformed Consent” series.

It’s too early to tell what this case means, but I do have some comments. Just because a treatment has been used on “hundreds” of patients does not mean that it has no serious acute side-effects. It only means that such side-effects may be relatively infrequent.

I may be overly conservative, but it seems we know a lot less about the sort of treatment used in this trial than we do about many other treatments. Occasionally, other novel treatments that seemed as if they ought to have been safe have not. Recall the TGN 1412 case (see post here) as well as the case of Jesse Geisinger noted above. Thus, in retrospect, it is easy to say that extreme caution in the first trials of the treatment was indicated. Instead, it often seems that people who work at the cutting edge of biotechnology are in a big hurry to develop their products. It is not clear from current reporting the extent that the design of the trials of tgAAC94 reflected the concerns of the 2003 NIH panel.

So we will keep an eye on this one. Some questions to keep in mind, based partly on the TGN 1412 story, are: how was the trial actually designed, what illnesses did subjects actually have, and what sort of informed consent did subjects give? Who actually carried out the trial (I assume it was not Targeted Genetics personnel)? Did previous animal or in vitro studies of tgAAC94 suggest the possibility of any bad adverse effects?

Legislators challenge Tenncare managed care rules

Tenncare, a health care reform program, essentially replaced the Medicaid program in Tennessee. TennCare was designed as a managed care model. It extended coverage to uninsured and uninsurable persons who were not eligible for Medicaid.

It has had its share of problems. It seems the legislature is now at odds with the officials who manage this program, resulting in “[poor] people being run over by the system.”

This issues are symptomatic of healthcare being taken over by governmental officials, whose incentives are often not aligned with that of clinicians or patients. The 191,000 patients cut from the system as part of a “financial overhaul” does ring of a rather severe ‘reform’ that is likely not within the values of the healthcare professionals at the core of the program.

The legislators in this state fortunately seem to know that the program has stepped beyond certain bounds into the realm of patient abandonment.

— SS

Legislators challenge TennCare rules

Citing concerns about enrollees’ rights, they do not OK rigid process for appeals

By ANITA WADHWANI
Staff Writer

Lawmakers refused yesterday to approve rules that place strict limits on TennCare enrollees who appeal being cut from the program.

Instead, lawmakers on the Government Operations Committee told state officials they needed to provide more evidence about why these rules are necessary.

The lawmakers questioned the officials about whether the appeal rules violated enrollees’ rights to prove they were being wrongly cut from TennCare.

We’re hearing stories about people being run over by the system. That’s the thing we don’t want to see and that’s the thing I know you don’t want to see,” Rep. Beverly Marrero, D-Memphis, told the state officials. “Our concern is that people being dis-enrolled be given the benefit of the doubt.”

New appeal rules have been in effect since the state began cutting about 191,000 people from TennCare this summer as part of Gov. Phil Bredesen’s overhaul of the financially troubled health-insurance program for the poor.

State officials want the rules to be permanent and apply to anyone turned down for TennCare coverage in the future.

… Officials with TennCare and the Department of Human Services, which administers the appeal process, said the rules were fair.

A state official first determines whether an appeal presents a “valid factual dispute” before determining if it can advance to a hearing, said Lee Ann Bruce, an assistant DHS commissioner.

If state officials can see no facts in the appeal that would warrant a hearing, it is turned down, she said.

“If it’s simply because you have a dispute with policies in place or can’t afford” to pay for your own health care, “that’s not a valid factual dispute,” she said.

However, lawmakers remained skeptical of the process.

The time lines set by the state for people to provide documents showing they should remain on the program — from 10 days in certain instances — may not be enough time for people who are mentally ill or who have a debilitating illness, Marrero said. Rep. Mike Kernell, D-Memphis, was among lawmakers who recounted anecdotes of constituents turned down for hearings.

… Michele Johnson, an enrollee lawyer with the Tennessee Justice Center, told lawmakers that in about 40% of the hearings they had observed, people who qualified for TennCare were told that evidence they provided was “not relevant.” Some were told to reapply,

which can take up to three months.

Lawmakers at times appeared frustrated when state officials said they could not answer questions and referred them to other state officials who were not at the hearing.

At the start of the meeting, Harper asked why DHS officials, who had been specifically requested to answer questions about the appeal process, were not present.

“I’m going to dispatch someone to the governor’s office,” Harper said. “It appears they (DHS) are the ones who created the rules. They should be here to defend them.”

DHS Commissioner Gina Lodge and Bruce hurried in to the meeting shortly afterward.

Healthcare IT Becomes an Adolescent … or has it?

By Jim Molpus, for HealthLeaders News, December 16, 2004

Healthcare IT Becomes an Adolescent&13;

Or has it?&13;

    Healthcare clinical information technology has been a kid for a long time. The parents-vendors, the government, providers and payors alike-have beamed proudly at the thought that this gangly kid would one day contribute to society. But so far the kid has just sort of skated along.&13;
    &13;
    After all, these parents have shelled out a lot of money, worried incessantly and planned diligently to raise the child. Now they are hoping the kid will realize that the time has come to learn how to work as part of a team and just generally grow the heck up … After years of putting off large IT projects because of concerns about compatibility, cost and integration, some of the largest health systems in the country spent hundreds of millions on products with acronyms like CPOE, EMAR and PACS. Wisconsin-based Aurora Health Care is spending $163 million to create a common electronic medical record for its 14 hospitals. Baylor Health Care System in Dallas is launching a five-year, $119 million IT initiative. Allina Hospitals & Clinics in Minneapolis will shell out some $200 million over four years. And giant Sutter Health in California will spend a whopping $1.2 billion in the next decade.&13;
    &13;
    On the implementation side, the industry learned from past mistakes, with many large projects making sure to include clinicians in selection and system design issues, and in providing enough support when systems went online.

Where is the evidence that the industry has “learned from past mistakes?” That would imply a significant body of literature on the lessons learned from healthcare IT failure.

A google search on “health IT failure”, “healthcare IT failure”, “healthcare information technology failure”, “healthcare IT problems”, etc. brings up very little on a worldwide basis.&13;

“Including clinicians in selection and system design issues” is so obviously necessary that one has to ask why this hasn’t been the case for the past several decades. One can go further and ask if clinicians are being “included” in selection and design issues in superficial ways, not as true leaders, in order to maintain MIS hegemony over this juicy piece of hospital territory.&13;

From the same journal, HealthLeaders News, Nov. 2004:&13;

    Big Spenders: The industry is replete with examples of IT projects that have run over budget, missed deadlines, and either stalled or failed outright. Many computerized order-entry projects founder, according to data compiled by KLAS Enterprises LLC, an Orem, Utah software evaluator. In its analysis of how some 200 hospitals use their CPOE systems, KLAS gave top ranking to Evanston (Ill.) Northwestern Healthcare last spring. But the vast majority of the hospitals surveyed barely registered on KLAS’ usage scale, which analyzes how deeply the order systems penetrate a hospital’s clinical work flow. In another widely cited example, Cedars-Sinai Medical Center, Los Angeles, scrapped its order-entry effort in 2003 after physicians rebelled.

Another problem is that there are few if any metrics on the efficiency of healthcare IT implementations. There is also little cross-institutional comparison. How would one tell if a project that is deemed “successful” was implemented at the best possible cost, or filled with costly delays, false go-lives, patchwork, massive additional expenditures, or even outright corruption?&13;

The experiences in the U.K. suggest healthcare IT is far from being an “adolescent.”&13;

If the great body of literature that the Healthcare IT industry is using to avoid multimillion dollar mistakes is hiding somewhere, could someone please point me to it?&13;

— SS&13;

Health Care Dysfunction Makes it to the Presidential Debate


In last night’s debate which included leading candidates from the Democratic Party for its presidential nomination, as reported by Mother Jones, Senator Bernie Sander (D-VT) said (per Mother Jones).

the current health care system is not only cruel, it is dysfunctional

The video is here.

So the concept of health care dysfunction has officially made it to the big time.

You Heard It Here First

What took so long?

We have been talking about health care dysfunction for a very long time, starting with a publication in 2003.

To better understand health care dysfunction, I interviewed doctors and health
professionals, and published the results in Poses RM.   A cautionary
tale: the dysfunction of American health care.  Eur J Int Med 2003; 14(2): 123-130. (link here). 
In that article, I postulated that US physicians were demoralized
because their core values were under threat, and identified five concerns:

1. domination of large organizations which do not honor these core values
2. conflicts between competing interests and demands
3.  perverse incentives
4. ill-informed, incompetent, self-interested, conflicted or even corrupt leadership
5.  attacks on the scientific basis of medicine, including manipulation and suppression of clinical research stuides

After that my colleagues and I have
tried to raise awareness of these and related issues, now mainly
through the Health Care Renewal blog.  We also set up FIRM – the Foundation for Integrity and Responsibility
in Medicine,  a US non-profit organization, to try to
provide some financial support for the blog.

Health Care Dysfunction is Multi-Dimensional

Unfortunately, one sentence in a presidential debate hardly does justice to a huge and multi-faceted set of concerns.  

Since 2003 we have broadened our thinking about what constitutes and causes US (and more global) health care dysfunction. Early on we noticed a number of factors that seemed to enable increasing
dysfunction, but were not much discussed.  These factors notably
distorted how medical and health care decisions were made, leading to
overuse of excessively expensive tests and treatments that provided
minimal or no benefits to outweigh their harms.  The more we looked, the more complex this web of bad influences seemed.  Furthermore, some aspects of it seemed to grow in scope during the Trump administration.

A brisk summary of these often complex issues follows.

 Threats to the Integrity of the Clinical Evidence Base

The clinical evidence has been increasingly affected by manipulation
of research studies.  Such manipulation may benefit research sponsors, now
often corporations who seek to sell products like drugs and devices and
health care services.  Manipulation may be more likely when research is
done by for-profit contract research organizations
(CROs). When research manipulation failed to produce
results to sponsors’ liking, research studies could simply be suppressed or hidden
The distorted research that was thus selectively produced was further
enhanced by biased research dissemination, including ghost-written
articles ghost-managed by for-profit medical education and
communications companies (MECCs). Furthermore, manipulation and
suppression of clinical research may be facilitated by health care
professionals and academics conflicted by financial ties to research sponsors.

 Deceptive Marketing

The distorted evidence base was an ingredient that proved useful in deceptive marketing of health care products and services. Stealth marketing
campaigns became ultimate examples of decpetive marketing.  Deceptive
marketing was further enabled by the use of health care professionals
paid as marketers by health care corporations, but disguised as unbiased
key opinion leaders, another example of the perils of deliberate generation of  conflicts of interest affecting health care professionals and academics. 

Distortion of Health Care Regulation and Policy Making

Similarly, promotion of health policies that allowed overheated selling
of overpriced and over-hyped health care products and services included
various deceptive public relations practices, including orchestrated stealth health policy advocacy campaigns.  Third party strategies used patient advocacy organizations and medical societies that had institutional conflicts of interest
due to their funding from companies selling health care products and
services, or to the influence of conflicted leaders and board members. 
Some deceptive public relations campaigns were extreme enough to be
characterized as propaganda or disinformation.

More recently,  as we noted here, we became aware of efforts by foreign powers to spread such disinformation for political, not just financial gain, e.g., in April, 2019,
we discussed evidence that Russia had orchestrated a systemic
disinformation campaign meant to discredit childhood vaccinations,
particularly for the measles, which was likely partly responsible for
the 2019 measles outbreak

Furthermore, companies selling health care products and services further enhanced their positions through regulatory capture,
that is, through their excessive influence on government regulators and
law enforcement.  Their efforts to skew policy were additionally
enabled by the revolving door,
a species of conflict of interest in which people freely transitioned
between health care corporate and government leadership positions. 

In the Trump era, we saw a remarkable increase in the incoming revolving
door, people with significant leadership positions in health care
corporations or related groups attaining leadership positions in
government agencies whose regulations or policies could affect their
former employers (look here).   We found multiple managers from and lobbyists for big health care
corporations being put in charge of regulation of and policy affecting –
wait for it – big health care corporations, a staggering
intensification of the problem of the revolving door.

Bad Leadership and Governance

Health care leadership was often ill-informed
More and more people leading non-profit, for-profit and government have
had no training or experience in actually caring for patients, or in
biomedical, clinical or public health research.  Lately, during the Trump administration, we began to find striking examples of top government officials expressing ill-informed,
if not outright ignorant opinions about medical, health care and public
health topics look here).  We had not previously expected leaders of government to
be personally knowledgeable about health related topics, but
traditionally they consulted with experts before making pronouncements.

Health care leaders often were unfamiliar with, unsympathetic to, or frankly hostile to their organizations’ health care mission, and/or health care
professionals’ values. Often business trained leaders put short-term revenue ahead of patients’ or the public’s health.  In addition, we began to see evidence that leaders of health care corporations were
using their power for partisan purposes, perhaps favoring their personal
political beliefs over their stated corporate missions, patients’ and
the public’s health, and even  corporate revenues. Then, we started seeing appointed government health care leaders who lacked medical, health care or public health background
or expertise but also whose agenda also seemed to be overtly religious or
ideological, without even a nod to patients’ or the public’ health (look here).
 
Leaders of health care organizations increasingly have conflicts of interest.   Moreover, we have found numerous examples of frank corruption of health care leadership.  Some have resulted in legal cases involving charges of bribery, kickbacks, or fraud.  Some have resulted in criminal convictions,
albeit usually of corporate entities, not individuals. 

In the Trump administration, corrupt leadership extends from the corporate world to the highest levels of the US government.  We discussed the voluminous reports of conflicts of interest and corruption affecting top leaders in the executive branch, up to and including the president and his family (look here).  One cannot expect effective enforcement of ethics rules and anti-corruption laws in such an environment

Abandonment of Health Care as a Calling

A US Supreme Court decision was interpreted to mean that
medical societies could no longer regulate the ethics of their members,
leading to the abandonment of traditional prohibitions on the commercial
practice of medicine. 
Until 1980, the US American Medical Association had  ruled that the
practice of medicine should not be “commercialized, nor treated as a
commodity in trade.”  After then, it ceased trying to maintain this
prohibition. Doctors were pushed to be businesspeople, and to give
making money the same priority as upholding their oaths. Meanwhile, hospitals and other organizations that provide medical care are increasingly run as for-profit organizations. The physicians and
other health care professionals they hire are thus providing care as
corporate employees, resulting in the rise of the corporate physician.  These health care professionals may befurther torn between their oaths, and the dictates of their corporate managers.

Perverse Incentives Put Money Ahead of Patients, Education and Research

We have extensively discussed the perverse incentives
that seem to rule the leaders of health care. Financial incentives may
be large enough to make leaders of health care organizations rich.  Incentives often prioritize financial results over patient care.  Some
seem to originate from the shareholder value dogma promoted in business
school, which de
facto translates into putting current revenue ahead of all other
considerations, including patient care, education and research (look here).

 Cult of Leadership

Health care CEOs tend
now to be regarded as  exalted beings, blessed with brilliance, if not
true “visionaries,” deserving of ever increasing pay whatever their
organizations’ performance.  This pheonomenon has been termed “CEO disease” (see this post). 
Afflicted leaders tend to be protected from reality by their
sycophantic subordinates, and thus to believe their own propaganda.

Managerialism

Leadership of health care organizations by managers with no
background in actual health care, public health, or biomedical
science has been promoted by the doctrine of managerialism which
holds that general management training is sufficient for leaders of  all
organizations, regardless of their knowledge of the organizations’
fundamental mission.

Impunity Enabling Corrupt Leadership

Most cases involving corruption in large health care organizations are resolved by legal settlements
Such settlements may include fines paid by the corporations, but not by
any individuals.  Such fines are usually small compared to the revenue
generated by the corrupt behavior, and may be regarded as costs of doing
business.  Sometimes the organizations have to sign deferred prosecution or corporate integrity agreements.  The former were originally meant to give young, non-violent first offenders a second chance (look here).  However, in most instances in which corruption became public, are no negative
consequences ensue for the leaders of the organizations on whose watch
corrupt behavior occurred, or who may have enabled, authorized, or
directed the behaviors.

Taboos

Some of the above topics rarely appeaedr in the media
or scholarly literature, and certainly seem to appear much less
frequently than their importance would warrant. We have termed the failure of such issues to create any echoes of public discussion the anechoic effect.

Public discussion of the issues above might discomfit those who
personally profit from the status quo in health care.  Those involved in the leadership
and governance of health care organizations and their cronies, also have
considerable power to damp down any public discussion that might cause
them displeasure. In particular, we have seen how those who attempt to blow the whistle on what really causes health care dysfunction may be persecuted.

However,in the Trump administration,  we began to also note examples of government officials attempting to squelch discussion of scientific topics that did not fit
in with its ideology, despite constitutional guarantees of speech and
press free from government control (look here).

What a witches’ brew, surely leading to a cruel and dysfunctional system.

Discussion

In 2017, we said that it was time to consider some of the real causes of health care dysfunction that
true health care reform needs to address, no matter how much that
distresses those who currently most personally profit from the status
quo.

Furthermore, in 2019 we asserted that all the trends we have seen since 2017 are towards tremendous government dysfunction, some of it overtly
malignant, and much of it likely enabling even worse health care dysfunction.

Now that health care dysfunction is in the headlines, we hope health care and public health professionals, patients, and all citizens
will have a much more vigorous response to it.  US health care dysfunction was
always part of the broader political economy, which is now troubled in
new and dangerous ways.  We do not have much time to act.

If not now, when?

If not us, who?  

Amendment to 5 CCR 1005-4, Newborn Screening and Second Newborn Screening

The Colorado Department of Public Health and Environment (CDPHE) is requesting that the Board of Health amend 5 CCR 1005-4 to delay the initiation of Pompe disease screening. The CDPHE Newborn Screening Program previously planned to begin screening for Pompe disease on July 1, 2016. However, following further analysis of the costs of screening for Pompe as well as the existing newborn screening expenditures and revenues, it has been determined that newborn screening for Pompe disease is no longer financially feasible at this time. Therefore, we are requesting that the Board of Health allow us to delay the initiation of Pompe disease screening until July 1, 2019. This additional time will provide the Newborn Screening Program the necessary time to reassess the financial impact of screening for Pompe disease and determine the necessity/amount for a fee increase. 

Despite the increased cost, the department continues to recommend including Pompe disease on the panel. That said, in light of the new financial information, we want to ensure we fully understand the impact to parents, hospitals, providers, and health insurance carriers. We are committed to receiving your feedback and will be including it in our analysis and communications with the Board of Health. We will continue to provide you updates as appropriate. 

The rule request hearing is scheduled for February 17, 2016 at 10 am at CDPHE, 4300 Cherry Creek Dr., South, Denver, CO 80246 with the rule making hearing occurring on April 20, 2016. 

For further information: Please contact Erica Wright at 303-692-3482 or Erica.Wright@state.co.us for questions or concerns.