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Thursday, June 29, 2017

Paying for health care

"Each year, 1 in every 20 Americans racks up just as much in medical bills as another 19 combined. This critical five percent of the U.S. population is key to solving the nation's health care spending crisis."
Good series at The Atlantic. Timely, in light of the week's (non) developments in the U.S. Senate.

For now I'll re-post my ugly little lifetime UTIL graphic.

The core question remains: how do we rationally, effectively, and equitably pay for health care. By differentially denying some care -- rationing? Using what (morally justifiable) economic criteria?

Given that Medicaid is squarely in the GOP funding reduction crosshairs in particular, it's useful to take a historical look at it.

2: Legislating Medicaid

When passed, as part of the Social Security Amendments of 1965 (P.L. 89-97), the Medical Assistance program—more commonly known as Medicaid—was not high-profile legislation. Unlike Medicare, there was no strong lobby pushing for its enactment. Its inclusion as one slab of the “three-layer” cake was almost fortuitous. A legislative draftsman said that he doubted that more than a half day was devoted to consideration of its provisions. Nor did it occasion much discussion in committee or floor debate. 

As legislation, Medicaid was often characterized as an “afterthought”—a casual and belated inclusion once the main business of Medicare was settled. Yet, within a few months after its initial implementation, the program was being described as a “sleeping giant” because of its phenomenal capacity for growth. Casual afterthoughts can often have major unforeseen consequences, and these two views of Medicaid may seem in conflict. But each reflects reflects a truth about the program. Though Medicaid came late in the legislative process, after other major structural decisions had been made, for Wilbur Mills—chairman of the House Ways and Means Committee and the most important legislative sponsor—the Medical Assistance Program was a significant benefit for the poor and structurally important as part of his overall design for health benefits in the Social Security Amendments of 1965. 

Medicaid was more than an “afterthought” for him. And for Wilbur Cohen—the most active and influential member of the administration—Medicaid was the culmination and ratification of a project begun almost twenty years earlier: to create a health benefit for the poor by incremental expansion, using the Social Security Act as a legislative vehicle. Medicaid was also more than an afterthought for some of the most knowledgeable and powerful legislative figures of that time. Moreover, when regarded from a longer perspective, as a program intended to survive and grow, the Medicaid legislation had about it considerably more design than generally supposed. Much of this design developed over time and was crafted with external circumstance and political environment especially in mind and shows considerable “forethought,” which helps explain Medicaid’s staying power and robust capacity for growth.

When Medicare and Medicaid were enacted into law, in the spring and summer of 1965, the political environment was unusually favorable and, important to add, quite unlike the harsh conditions under which the Medicaid program later survived and grew. Following the election of November 1964, the Democrats controlled both the House and Senate, with a super-majority in the House. Lyndon Johnson had won a landslide victory with a strong mandate to complete the unfinished work of the slain president, John Kennedy. For Democrats, this was the largest window of opportunity since the New Deal administration of 1932. In these circumstances, it was no great feat to include Medicaid as part of the “three-layer cake.” But that perspective loses sight of the extent to which Medicaid was already in being before it was enacted and specially adapted to survive in a hostile environment.

Smith, David G. (2015-06-29T23:58:59). Medicaid Politics and Policy: Second Edition (Kindle Locations 634-660). Transaction Publishers. Kindle Edition.
In round numbers, both the House and Senate "Repeal and Replace" bills envision cutting Medicaid funding by about $800 billion across ten years. Stay tuned.

Just a bit more history:
The postwar years were a time in which private, especially employer-sponsored, health insurance grew rapidly (supra, 12). This development also diverted attention from the plight of the poor and medically needy. Many of those with employer-sponsored insurance saw little need to fight hard for national health insurance or make common cause with the uninsured poor, since they and their families were adequately covered. Moreover, the elderly—who were notoriously difficult to insure and also sympathetically perceived—had plenty of champions and no need to ally themselves with a stigmatized group that had little to contribute.
During this era, “welfare medicine” was marginalized, rather like a poor relation that is sometimes “taken in” but never fully included and has to survive on leftovers. The cause had champions, but they were not effectively heard in a political system that favored entrenched and well-organized interests.
Medical Assistance for the Aging, more popularly known as Kerr-Mill, was enacted in 1960 as part of the Social Security Amendments of that year. It is of historic importance because it became the template for Medicaid in 1965. The developments that led to Kerr-Mills also provide an instructive example of incrementalism in health policy, revealing both the potential of categorical incrementalism as well as some of its noxious properties.
For health and social policy, incrementalism was much in fashion in the 1950s. Efforts at comprehensive restructuring failed or were unpopular, in part, because of a return to “normalcy” after the New Deal and the war years. The Cold War and McCarthyism deepened the conservative mood and encroached upon the domestic agenda. It was also a time of divided government, a president with a minimalist domestic agenda, and of legislative committee “baronies” controlled by southern Democrats. Under the circumstances, incrementalism in domestic policy made sense. And creatively employed, it could be a powerful engine for change.
Another element in accounting for the latent power of incrementalism was the nature of the Social Security Act and its strategic position with respect to social legislation. In 1960, the act had eight substantive titles that covered most of federal health and welfare policy, except for the Public Health Service and the Food and Drug Administration. Because it was largely an aggregate of different titles, it lent itself readily to tinkering with individual programs, adding a paragraph, a subtitle, or even a whole new title. Much of its purpose was to get timely payments to individual beneficiaries, so it had a periodicity and a “must pass” element that invited its use as a vehicle for related amendments. The Social Security Act fell under the jurisdiction of the House Ways and Means Committee, which virtually assured its passage. Such bills, when passed by Congress, were almost “veto proof,” since no president wanted the onus of holding up twenty million Social Security checks. [ibid, Kindle Locations 745-772]
 An interesting political history, to be sure. And, political support for social welfare programs for the poor has never been lower than I can recall across my 71 years.
"We've got to do something to reinject free market forces into this environment. And look if we can't get this done, I have made clear if we can bring free market forces to bear, we can bring down cost for middle Americans." - Utah GOP Senator Mike Lee, Face the Nation, July 2nd
Yeah, the totemic, wholly curative "free market." Well, how can there be a profitable "market" aimed at those with no discretionary resources (the poor)? What good is a HSA if you've no funds of your own to put in it? What is the utility of any "subsidies" if the cost of health care goods and services nonetheless remain largely out of reach? Recall my prior post Rationing by 'Price'?

I repost a graphic I did earlier.

My personal sociopolitical ideological axiom is that markets properly exist to serve humanity, not the other way around.

More to come...

Monday, June 26, 2017

Up next: "Improving Global Health: Focusing on Quality and Safety"

I saw this at THCB and signed up for it. We'll see. It's a nominally free "MOOC" -- though they keep trying to get $99 out of you for a "Certificate upgrade." I already have a health care QI "Cert" from IHC (and had an ASQ CQE Cert for years prior to retiring it). At 71, I'm past the days of needing any "certs" for "career advancement." I'm just interested in the learning. Given the uncertainties of my daughter's illness (she just finished chemo round 4), I just hope I can devote the time to get through the entire course. If they let you buy the certificate later, I may do that. The $99 is no issue.
"We are at a critical inflection point in global health. We have seen improvements in access to care, but struggle to improve human health. A key component of this equation is quality of care.

Improving access to healthcare is only as useful as the quality of care provided. Many agree that quality is important – but what is it? How do we define it? How do we measure it? And most importantly, how might we make it better?

The course is designed for those who care about health and healthcare and wish to learn more about how to measure and improve that care – for themselves, for their institutions, or for their countries. Each session will be interactive and provide concrete tools that students can use. We will empower you to raise questions, propose concrete solutions, and promote change.

We have assembled leading thinkers from around the globe – not only people who are experts – but people with real, hands-on experience running organizations, hospitals, and ministries of health. So join us – whether you are a physician, nurse, or other healthcare provider, if you are a student of medicine, public health, or health policy, or a patient who simply cares about getting good care – this course is for you."


MACRA is a $15 billion boondoggle that the best research shows will neither improve quality nor control costs. Paying doctors for quality (e.g., doing a blood pressure exam) or efficiency may make sense theoretically, but it doesn’t work...

Some of the (interlinked and overlapping) factors I think about, and have blogged on at some recurrent length here:
dx accuracy and precision;
px/tx efficacy;
Process QI;
Organizational culture;
Clinical pedagogy;
Clincal science;
Technologies (e.g., HIT, AI, applied "Omics");
Economics -- business and public policy/legislative realities.

They provide scrolling (and downloadable) text transcripts with the videos.



My next-of-kin caregiver duties have seriously hampered my normal reading pace, but here are a few titles in various stages of completion, to be reported on soon.

Much of the motive here maps to my interest in "Natural Language Processing," and its prospective utility (if any) regarding applied AI in health care.


EHR users have long complained about "vendor lock," the circumstance resulting from the large sunk cost of buying (uh, "licensing") a platform and the lack of data exchange / '"interoperability" between systems. A post over at Naked Capitalism is broadly intriguing in this regard.
US Copyright Office Wimps Out on Right to Repair
Posted on June 27, 2017 by Jerri-Lynn Scofield

By Jerri-Lynn Scofield, who has worked as a securities lawyer and a derivatives trader. She now spends much of her time in Asia and is currently researching a book about textile artisans. She also writes regularly about legal, political economy, and regulatory topics for various consulting clients and publications, as well as scribbles occasional travel pieces for The National.

As more and more devices require software to operate, copyright holders employ a number of measures that thwart an end user’s right to repair a product s/he ostensibly owns.

As the Electronic Frontier Foundation (EFF) recognizes, although in theory one may own a device outright, one’s only allowed to license the software necessary to make the device work properly. The terms of that license may preclude any efforts to tinker with the device, reverse engineer it, or have a third party undertake a repair…
Very interesting post. Including the comments.

BTW, Adrian Gropper, MD has long been an insistent voice for "open source" in Health IT.

Registration Link


More to come...

Sunday, June 25, 2017

#HealthcareBill, the Kellyanne Conway solution

Simple. Problem solved. @KellyannePolls.

From the USC Annenberg Center:
As Senate rushes ahead, the missing debate over Medicaid poses dire risks for rural, elderly Americans
Trudy Lieberman

Has the conversation swirling around replacing the Affordable Care Act focused on the wrong thing?

For weeks the steady stream of tweets, studies, numbers, and pleas to save Obamacare has largely focused on the people who gained covered through the health law’s state insurance exchanges. But under the ACA’s Medicaid expansion, in my view the most important feature of the law, far people gained health insurance coverage. For millions of people, that was the first time in their lives they got insurance and care they never had before...

You would think such an achievement in improving the health and well-being of so many citizens would be something to celebrate — perhaps something akin to the excitement expressed when Medicare became law in 1965, making it possible for millions of old people to get health insurance and medical care at a time in life when their incomes and health had declined. Instead, Medicaid has become something to tear down, emerging as the central focus of Republican attempts to rid the country of the Affordable Care Act. “Medicaid is growing at an unsustainable pace,” said Pennsylvania Sen. Pat Toomey recently. “If we’re going to overhaul this program which we need to do by virtue of Obamacare, we can at least put it on a sustainable path.”...

But there’s another reason: Medicaid carries the stigma of being a welfare program, and Americans don’t like welfare. Typical of that sentiment is one email I received earlier this year from a man in the Midwest, who said, “I LOVE the idea of Medicaid reform. We can save millions, probably billions by putting people to work who can work and sending people who won’t comply back to their own country.”...

Medicaid’s untold story also includes Americans who have received benefits under the traditional Medicaid program — for example, the millions of middle class families who’ve come to rely on it to fund long-term care for a family member. Medicaid pays for about half of all nursing home stays. That’s another subject that’s been missing from the media until this past week. GOP proposals to slice more than $800 billion from the Medicaid program mean that states will have much less money to funnel into nursing home and other forms of care for the elderly in their communities. Where are the media stories on this? Where are protests from families who would be affected?...
There seems to be a distinct odor of Persecute the Poor, Halt, and Lame in the air these days.

From The Atlantic:
The Kabuki Theater of the AHCA
Normally, a bill this unpopular wouldn’t stand a chance. But Senate Majority Leader Mitch McConnell’s health-care bill seems designed to let reluctant senators amend it, and claim victory

The United States has never had a Senate leader as ruthless, as willing to bend, distort and break the rules, traditions and precedents of the Senate as Mitch McConnell. And the Senate has probably never had a majority leader as effective at accomplishing his goals as Mitch McConnell—making even Lyndon Johnson look like a neophyte in comparison.

That is why no one should believe that the McConnell-crafted health-policy bill is dead, despite the growing opposition and the fact that the overwhelming majority of health-policy analysts and health providers say the bill is a walking disaster. It eviscerates Medicaid—a program widely misunderstood as simply insurance for poor people, but which uses most of its money for long-term care for the elderly, and basic protection for the disabled and mentally ill populations. The overall Medicaid cuts, while spread over a longer time frame, are more severe than the draconian House bill.

The McConnell bill removes the protection of lifetime and annual limits, meaning someone with a serious illness like cancer could be cut off in the middle of chemotherapy. It also fails the so-called “Kimmel test,” named for Jimmy Kimmel after he faced the horror of a newborn son born with a devastating heart ailment. With this bill, a newborn with a major problem requiring weeks in intensive care and multiple serious surgeries would pass both the annual and the lifetime limit within his or her first few months of life. And because the bill allows for insurers to charge much more to those with pre-existing conditions, a newborn who leaves the hospital without exceeding the lifetime limit might be unable to afford insurance for the rest of his or her life.

More generally, the bill is structured so that essential coverage provisions can be dropped, and insurers will be able to offer barebones plans with low premiums—and sky-high deductibles, far greater than those imposed by plans on the Affordable Care Act exchanges. Many people could have insurance that would be faux-insurance, something appearing great until they actually needed it, and discover that their ailment, or pregnancy, was not covered, or if it was, requires them to pay $7,500 out of pocket before it pays a dime...
My younger daughter Danielle, should she live long enough in her ghastly battle with Stage IV pancreatic cancer, could be among those left without any coverage should this kind of crap be enacted. She's a Kaiser member for now, but will soon likely be on Medi-Cal (she's finally lost her job, and will have to apply for SSI and Medi-Cal).

From Esquire:
Kellyanne Conway Says the Republican Medicaid Cut Isn't a Cut to Medicaid
New frontiers in mendacity

It's one thing to lie about the size of an inauguration crowd. It's entirely another to get on national television and present blatant non-facts about whether your party's Double Secret Healthcare Bill will cut people's coverage. Of course, this was always inevitable: This White House has such a staggering disdain for the concept of objective reality that it was bound to reflexively misrepresent the facts on something that really matters.

That's how we got to Kellyanne Conway on Sunday. She had the extraordinary nerve to go on ABC's This Week to tell George Stephanopoulos that the Republican healthcare plan's $800 billion cut to Medicaid isn't a Medicaid cut...
I wonder if she takes her 70% taxpayer-subsidized premiums FEHB health care coverage?

Senate Bill also taking fire from the Far Right.

UPDATE: CBO Score Report now published.
The Congressional Budget Office and the staff of the Joint Committee on Taxation (JCT) have completed an estimate of the direct spending and revenue effects of the Better Care Reconciliation Act of 2017, a Senate amendment in the nature of a substitute to H.R. 1628. CBO and JCT estimate that enacting this legislation would reduce the cumulative federal deficit over the 2017-2026 period by $321 billion. That amount is $202 billion more than the estimated net savings for the version of H.R. 1628 that was passed by the House of Representatives.

The Senate bill would increase the number of people who are uninsured by 22 million in 2026 relative to the number under current law, slightly fewer than the increase in the number of uninsured estimated for the House-passed legislation. By 2026, an estimated 49 million people would be uninsured, compared with 28 million who would lack insurance that year under current law.

Following the overview, this document provides details about the major provisions of this legislation, the estimated costs to the federal government, the basis for the estimate, and other related information, including a comparison with CBO’s estimate for the House-passed act...


See you there.


Very interesting.

See my prior post about my "Omics" concerns.


This looks very worthy. We need more women leaders in health care.
More to come...

Tuesday, June 20, 2017


The GOP is still trying to sell the lame canard that "ObamaCare" was written and passed "in secret" by Democrats with no Republican input. That's simply not true. I followed every draft of the legislation as it wound its way through Congress. See my 2009 post "Public Optional."

It passed with no GOP votes, yes, but it did contain 147 GOP amendments, and had been the subject of many hours of hearings spanning a year.
"You're going to have such great health care, at a tiny fraction of the cost—and it's going to be so easy.” - Donald Trump, Oct 2016 rally in Florida
apropos of the federal health policy debate, see my prior post Rationing by "Price."
Just got my Miraca Life Sciences bill stemming from a recent local dermatology visit biopsy for a chronic arms and torso rash I've had for about 30 years. The "Billed Charges" total came to $1,565.00. Medicare paid $439.39. Part-B "Patient Amount due" was $112.11 (I paid it immediately). Were Trump HHS Secretary Tom Price to get his "balance billing" way, I'd be on the hook for an additional $1,013.40.
See also my prior posts on "An American Sickness." Buy her book. Also, stay up with the #ShowMeTheBill hashtag activity here.

Worth re-posting a quick graph I did a little while back.

The core question remains one of how we pay for health care equitably.


Just Google "H.R. 1628." 132 pages in my PDF download. 36 allusions to the administrative/regulatory discretion of "the Secretary" (HHS Secretary Tom Price -- e.g., "as the Secretary shall determine..." " determined by the Secretary"). The words "quality," "improvement," and "affordability" are nowhere to be found. "Subsidy"? How about "SEC. 131. REPEAL OF COST-SHARING SUBSIDY." (pg. 59)

Hmmm... "Sec. 117. Permitting States to apply a work requirement for nondisabled, non-elderly, nonpregnant adults under Medicaid."

Wonkistan will be busy today with reactions. News reports of protests and arrests outside Senator Mitch McConnell's office.
"FEHB" is not cited in the bill. FEHB is the program that gives members of Congress a 70% taxpayer subsidy on their health care premiums.

Click to enlarge.

Again, see my prior posts reviewing An American Sickness.

Let's see, the usual stuff: "A third to half of health care is wasteful, unnecessary, and even harmful, blah, blah, blah..." Not to summarily discount all of that widely repeated assertion, but we are not gonna Lean Process QI our way to macro expenditure reductions getting even close to that. Similarly with respect to more accurate dx's and more efficacious tx's. Health care will likely remain a vexingly expensive endeavor. I first addressed this stuff in 2009:
Some reform advocates have long argued that we can indeed [1] extend health care coverage to all citizens, with [2] significantly increased quality of care, while at the same time [3] significantly reducing the national (and individual) cost. A trifecta "Win-Win-Win." Others find the very notion preposterous on its face. In the summer of 2009, this policy battle is now joined in full fury.
BTW, per this post, I should add that I don't buy the claim that everyone in the space is "losing money."

Our politics are divided. They have been for a long time. And while I know that division makes it difficult to listen to Americans with whom we disagree, that’s what we need to do today.

I recognize that repealing and replacing the Affordable Care Act has become a core tenet of the Republican Party. Still, I hope that our Senators, many of whom I know well, step back and measure what’s really at stake, and consider that the rationale for action, on health care or any other issue, must be something more than simply undoing something that Democrats did.

We didn’t fight for the Affordable Care Act for more than a year in the public square for any personal or political gain – we fought for it because we knew it would save lives, prevent financial misery, and ultimately set this country we love on a better, healthier course.

Nor did we fight for it alone. Thousands upon thousands of Americans, including Republicans, threw themselves into that collective effort, not for political reasons, but for intensely personal ones – a sick child, a parent lost to cancer, the memory of medical bills that threatened to derail their dreams.

And you made a difference. For the first time, more than ninety percent of Americans know the security of health insurance. Health care costs, while still rising, have been rising at the slowest pace in fifty years. Women can’t be charged more for their insurance, young adults can stay on their parents’ plan until they turn 26, contraceptive care and preventive care are now free. Paying more, or being denied insurance altogether due to a preexisting condition – we made that a thing of the past.
We did these things together. So many of you made that change possible.

At the same time, I was careful to say again and again that while the Affordable Care Act represented a significant step forward for America, it was not perfect, nor could it be the end of our efforts – and that if Republicans could put together a plan that is demonstrably better than the improvements we made to our health care system, that covers as many people at less cost, I would gladly and publicly support it.

That remains true. So I still hope that there are enough Republicans in Congress who remember that public service is not about sport or notching a political win, that there’s a reason we all chose to serve in the first place, and that hopefully, it’s to make people’s lives better, not worse.

But right now, after eight years, the legislation rushed through the House and the Senate without public hearings or debate would do the opposite. It would raise costs, reduce coverage, roll back protections, and ruin Medicaid as we know it. That’s not my opinion, but rather the conclusion of all objective analyses, from the nonpartisan Congressional Budget Office, which found that 23 million Americans would lose insurance, to America’s doctors, nurses, and hospitals on the front lines of our health care system.

The Senate bill, unveiled today, is not a health care bill. It’s a massive transfer of wealth from middle-class and poor families to the richest people in America. It hands enormous tax cuts to the rich and to the drug and insurance industries, paid for by cutting health care for everybody else. Those with private insurance will experience higher premiums and higher deductibles, with lower tax credits to help working families cover the costs, even as their plans might no longer cover pregnancy, mental health care, or expensive prescriptions. Discrimination based on pre-existing conditions could become the norm again. Millions of families will lose coverage entirely.

Simply put, if there’s a chance you might get sick, get old, or start a family – this bill will do you harm. And small tweaks over the course of the next couple weeks, under the guise of making these bills easier to stomach, cannot change the fundamental meanness at the core of this legislation.

I hope our Senators ask themselves – what will happen to the Americans grappling with opioid addiction who suddenly lose their coverage? What will happen to pregnant mothers, children with disabilities, poor adults and seniors who need long-term care once they can no longer count on Medicaid? What will happen if you have a medical emergency when insurance companies are once again allowed to exclude the benefits you need, send you unlimited bills, or set unaffordable deductibles? What impossible choices will working parents be forced to make if their child’s cancer treatment costs them more than their life savings?

To put the American people through that pain – while giving billionaires and corporations a massive tax cut in return – that’s tough to fathom. But it’s what’s at stake right now. So it remains my fervent hope that we step back and try to deliver on what the American people need.

That might take some time and compromise between Democrats and Republicans. But I believe that’s what people want to see. I believe it would demonstrate the kind of leadership that appeals to Americans across party lines. And I believe that it’s possible – if you are willing to make a difference again. If you’re willing to call your members of Congress. If you are willing to visit their offices. If you are willing to speak out, let them and the country know, in very real terms, what this means for you and your family.

After all, this debate has always been about something bigger than politics. It’s about the character of our country – who we are, and who we aspire to be. And that’s always worth fighting for.

More to come...

Friday, June 16, 2017

Given that "EHRs are a dying technology," should we kill MU Stage 3?

Picking back up on a recent riff I started pursuant to a young (English major) reporter's assertion that "EHRs are a dying technology." MUfraud

The American Hospital Association now recommends doing away with MU Stage 3.
AHA Calls for Stage 3 Meaningful Use Cancellation and More
AHA is calling for CMS to cancel Stage 3 Meaningful Use as part of recommended changes to federal EHR reporting changes.

The American Hospital Association (AHA) recently submitted a letter [pdf] to CMS requesting reduced administrative complexity as a way to save healthcare providers billions in annual costs, including the cancellation of Stage 3 Meaningful Use.

AHA outlined 29 recommendations to reduce regulatory burden in response to the federal organization’s request for information regarding CMS flexibilities and efficiencies

“The regulatory burden faced by hospitals is substantial and unsustainable,” opened AHA. “As one small example of the volume of recent regulatory activity, in 2016, CMS and other agencies of the Department of Health and Human Services (HHS) released 49 hospital and health system-related rules, comprising almost 24,000 pages of text.”...
Given that explicit references requiring Meaningful Use "Stages" are found nowhere in the ARRA/HITECH statute (P.L. 111-5), this action would appear to be fully within HHS/CMS discretion. Seems to me that HHS Secretary Tom Price could simply order the killing on MU3 himself. The MU incentive money is pretty much all out the door anyway, and Price is documentably no friend of MU. From Healthcare IT News back in January:
Tom Price takes aim at the inefficiencies of meaningful use, questions how to pay for precision medicine
The HHS nominee decries a law that has turned physicians "into data entry clerks." Meanwhile, genomics represents a "brave new world," he said – but "the challenges of how we afford to be able to make that available to our society are real."
Notwithstanding that I am no fan of Dr. Price (see here and here as well), you have to give him his due here:
"Electronic health records are so important because, from an innovation standpoint they allow the patient to have their health history with them at all times and be able to allow whatever physician or provider to have access to that," Price responded. "We in the federal government have a role in that, but that role ought to be interoperability: to make sure the different systems can talk to each other so it inures to the benefit of the patient.”

With regard to the EHR Incentive Program, "I've had more than one physician tell me that the final rules and regulations related to meaningful use were the final straw for them," said Price. "And they quit. And they've got no more gray hair than you or I have. And when that happens we lose incredible intellectual capital in our society."...
Ah, yes, "interoperability." I've been griping about what I have called "interoperababble" for years on this blog.

"We in the federal government have a role ... but that role ought to be interoperability..."
ONC missed the boat on that right at the outset by not requiring "standard data" (i.e., a metadata/dictionary standard) as part of EHR certification. APIs may be just fine for data exchange among lightweight consumer-facing apps comprising few data elements in need of exchange, but EHRs (which are not "dying") typically house around 4,000 variables -- hundreds of which may have to be exchanged during any given "interop" episode of care involving multiple providers on different systems.

Finally (pedantically, for my umpteenth time), no amount of calling n-dimensional "interfaced" point-to-point data translation/exchange "interoperability" will make it so. Had we "Type-O" universal standard data (my "lifeblood of health care" analogy again), we might come closer to conforming to the IEEE definition of "interoperability."


Just updated my March 2017 post "Health Care Needs an Uber Like It Needs Another Gruber."


More to come...

Wednesday, June 14, 2017

A bad day in Alexandria

OK, cheap @RandPaul political talk on Twitter a year ago.

Notwithstanding that "shooting at the government" comprises the exact Constitutional and statutory definition of "treason."

I wish Congressman Steve Scalise and the other three shooting victims full and fast recoveries. As horrific as the incident was, there could have been dozens of people killed.

apropos of health care, see
What Bullets do to Bodies

Thursday, June 8, 2017

"EHRs are a dying technology?"

From yet another press report on the eClinicalworks fraud settlement:
The eClinicalWorks False Claims Act case: Implications for health IT

Experts say the False Claims Act case against eClinicalWorks highlights problems in health IT that center on a lack of interoperability, the failure of meaningful use and the failure of electronic health records, or EHRs.

The Department of Justice noted in its press release about the case that a lack of interoperability played a role: "ECW's [eClinicalWorks'] software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW's software to the software of other vendors."

Kirk Nahra, an attorney at Wiley Rein LLP in Washington, D.C., who specializes in privacy, information security and compliance issues, explained. "One of the points [of these EHR certification requirements] ... is [for] systems to be able to work together," Nahra said. "[It's] the whole idea of interoperability."...
To Kate McCarthy, senior analyst at Forrester Research, this case just reinforces something she's believed in for a while: "It's kind of mystifying that they were able to get away with this as long as they did. But my opinion on health records has been, for a while, that [EHRs are] a dying technology."

A perfect design for failure

McCarthy explained that healthcare organizations try to use EHRs to run hospitals and drive everything, from scheduling to patient workflow to revenue cycles, in addition to using EHRs simply as clinical document storage -- which is what they are more suited for than anything else, she said.

"They're systems of record," McCarthy said. "They're not systems of insight, and they're not systems of engagement. And so the way that people have tried to make them work in the industry was basically a perfect design for failure."

But more than the failure of EHRs, McCarthy said she believes this case against eClinicalWorks also demonstrates the failure of meaningful use.

"The issue I see is more that meaningful use, in and of itself, is a pretty big failure," she said. "And even organizations that are successfully attesting meaningful use are not meeting customer organizations' expectations with the products and services that they're delivering."

She added that "not only have we not [achieved meaningful use], but now vendors are out there faking meaningful use attestation."...

I know critics are having great sport these days piling on the Meaningful Use program, summarily calling it an unequivocal "failure." While I have never held fire criticizing the initiative where I found it necessary (e.g., "interoperababble," anyone) -- even while working for the HealthInsight REC --  I'm not so sure. I find the results decidedly mixed.
Responses shortly (my daughter's been finishing chemo round 3 today). First of all, briefly, I take issue with the summary conflation: whether the Meaningful Use program has "failed" (in what regard?) is a separate issue from whether EHRs have "failed" (and, they decidely have not; paper charts are not "better," the converse is true. All we can differ over is the relative extent).

None of which is to argue that the "current state of HIT is 'acceptable'." When you work in QI, little to nothing of the status quo is ever "acceptable." Technology is never static, and to the extent that dominant market incumbency stifles 'innovation" in any business/tech domain, it has nil to do with technology per se. (And, yes, I'm hip to the phrase "regulatory capture." I dispute the extent to which it applies in Health IT -- in marked contrast to, say, the FIRE sector.)

Two broad accusations stand out in general as proffered by MU critics: [1] "Interoperability" has yet to be accomplished, and [2] we have failed to "bend to cost curve (down)."

Fair enough. Search back through the MU-governing ARRA/HITECH Act (Public Law 111-5, pdf). Interoperability is alluded to exactly twice, once with respect to "promoting research into interoperability (which has indeed commenced, however haltingly)," and once touting the (obvious) utility of interoperability with respect to pubic health databases and "registries."

Search also on "cost curve" and its numerous synonym phrases. You won't find anything. For an in-depth at why health care costs continue to rise despite all of the policy chatter and health IT initiatives, you can't do better that Elisabeth Rosenthal's fine book "An American Sickness." Yes, it was hoped and intended that HIT would play a role in reducing health care costs, but other far more potent economic factors keep confounding that goal (and, we simply cannot know where costs would be today absent the significant accelerated penetration of HIT pursuant to HITECH).


Coming shortly, after I look into this (below) further.

A "free" 8-week online course.
"Participants in this 8-week course will engage with top experts in the field of public health as they grapple with the nature of high-quality healthcare: What is quality? How do we define it? How is it measured? And most importantly, how can we make it better? Whether you’re a healthcare provider; student of medicine, public health, or health policy; or a patient who simply cares about getting good care—this course is for you."
We'll see what's new since I got my health care QI Cert in 1994.

More to come...

Tuesday, June 6, 2017

Should we abolish the ONC?

"The Office of the National Coordinator for Health Information Technology (ONC) is the lead agency charged with formulating the federal government’s health information technology (IT) strategy and coordinating federal health IT policies, standards, programs, and investments. ONC supports the Department’s goal to strengthen health care by modernizing the care delivery infrastructure of the nation through the adoption, implementation, meaningful use, and optimization of health IT.

The FY 2017 Budget for ONC is $82 million, $22 million above FY 2016. This Budget reflects ONC’s commitment to advancing progress towards a safe and secure nationwide system of interoperable health IT that focuses on safety and usability. Through the engagement and collaboration of public and private sector stakeholders, ONC will facilitate care delivery transformation and better health and health care nationwide.

In FY 2017, ONC will focus on encouraging market transparency and competition, improving electronic health record usability, and offering technical assistance to providers to help them get the most out of their health IT."
In light of my prior post.
Go to Search around for "eClinicalWorks" (including via the "Newsroom" link). See if you find any mention of the eCW fraud.

First "Newsroom" hit (which ranks eCW at 3rd):
Health Care Professional EHR Vendors
Certified Health IT Vendors and Editions Reported by Ambulatory Health Care Professionals Participating in the Medicare EHR Incentive Program

Note: Certified health information technology (health IT) meets the technological capability, functionality, and security requirements adopted by the Department of Health and Human Services. The order above reflects vendors of commercial certified health IT only; totals for self-developed certified health IT are summarized as a whole. 2014 certified health IT is certified under the 2014 Edition Health Information Technology Certification Critiera, and 2011 certified health IT is certified under the 2011 Edition Health Information Technology Certification Criteria...
"Certified health information technology (health IT) meets the technological capability, functionality, and security requirements adopted by the Department of Health and Human Services."

Unless it doesn't.

ONC "$82 million" budget this year? That'd perhaps pay for Trump's 2017 weekend trips to Mar-a-Lago. That's less than HIMSS recent annual gross (~$97 million, per their IRS Form 990 via Guidestar). Hey, Donald, while you're privatizing the FAA, why don't you sell off ONC to HIMSS? They just bought Health 2.0. We could have one Big Happy Free Market HIT Family.


From Health Affairs,
Across all medical specialties, there is a severe lack of high-quality clinical evidence, in part because the gold standard for evidence is large-scale randomized controlled clinical trials. Such trials are on an unsustainable cost trajectory, as they require expensive, stand-alone data capture infrastructures. Furthermore, they typically enroll highly selected populations that are not necessarily representative of real-world patients. Although the emergence of the electronic health record (EHR) holds great promise for generating much-needed evidence, medical research lags far behind other industries in its ability to use big data to get the answers decision makers need in health care. The ability to harness good quality, usable data from EHRs will likely be as revolutionary to health care as the Internet was to other industries.

The problem is complex, and one facet of the issue is that data from health systems are not interoperable; for example, information such as date of birth, blood pressure, or diagnoses can be recorded in a myriad of ways. Although the Centers for Medicare and Medicaid Services encourages and incents “meaningful use” of EHRs, these systems are customizable to each institution’s needs, and as a result, data from individual health care systems and providers are housed in silos of babel—with limited ability to exchange information between them. Compounding the issue, most organizations erected proprietary systems of digital health data capture before standardized formats were developed and before thoughtful consideration about reuse of these data for research activities gained traction. As a result, it has been infeasible to ask questions as seemingly simple and important as “Which dose of aspirin is associated with better outcomes?”
To counter these problems, the Patient-Centered Outcomes Research Institute (PCORI) funded PCORnet, the National Patient-Centered Clinical Research Network, to support clinical research. PCORnet has built strong partnerships between clinical researchers and patient advocacy networks. In addition, PCORnet has established a Common Data Model to support pragmatic trials and observational research. Use of PCORnet’s Common Data Model will enable large-scale clinical research from data gathered during patient care as well as rapid execution of queries. Data can be collected and harmonized across more than 130 diverse organizations representing more than 122 million individuals who had a medical encounter in the past five years. Additionally, 41 million patients are available for enrollment in clinical trials and other studies...
PCORI was legislated as part of "ObamaCare" (PPACA), not HITECH, btw. If the GOP actually goes through with ACA repeal, PCORI will go down the tubes as well.

More to come...

Saturday, June 3, 2017

Fraud at eClinicalWorks. Are they alone in this regard?

Electronic Health Records Vendor To Pay The Largest Settlement In The District Of Vermont
eClinicalWorks LLC to Pay $155 Million to Resolve Civil False Claims Act Allegations

BURLINGTON, VT – One of the nation’s largest vendors of electronic health records (EHR) software, eClinicalWorks (ECW), and certain of its employees will pay a total of $155 million to resolve a False Claims Act lawsuit alleging that ECW misrepresented the capabilities of its software, the Justice Department announced. The settlement also resolves allegations that ECW paid kickbacks to certain customers in exchange for promoting its product. ECW is headquartered in Westborough, Massachusetts.

“This settlement is the largest False Claims Act recovery in the District of Vermont and we believe the largest financial recovery in the history of the State of Vermont,” said Acting United States Attorney for the District of Vermont Eugenia A.P. Cowles. “This significant recovery is a testament to the hard work and dedication of this office and our partners in the Commercial Litigation Branch of the Civil Division and at HHS. This resolution demonstrates that EHR companies will not succeed in flouting the certification requirements.”

The American Recovery and Reinvestment Act of 2009 established the Electronic Health Records (EHR) Incentive Program to encourage healthcare providers to adopt and demonstrate their “meaningful use” of EHR technology. Under the program, the U.S. Department of Health and Human Services (HHS) offers incentive payments to healthcare providers who adopt certified EHR technology and meet certain requirements relating to their use of the technology. To obtain certification for their product, companies that develop and market EHR software must attest that their software satisfies applicable HHS-adopted criteria and pass testing by an accredited, independent, HHS-approved certifying entity.

In its complaint-in-intervention, the government contends that ECW falsely obtained that certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification. For example, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the company modified its software by “hardcoding” only the drug codes required for testing. In other words, rather than programming the capability to retrieve any drug code from a complete database, ECW simply typed the 16 codes necessary for certification testing directly into its software. ECW’s software also did not accurately record user actions in an audit log, and in certain situations did not reliably record diagnostic imaging orders or perform drug interaction checks. In addition, ECW’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW’s software to the software of other vendors. As a result of these and other deficiencies in its software, ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.

“Every day, millions of Americans rely on the accuracy of their electronic health records to record and transmit their vital health information,” said Acting Assistant Attorney General for the Civil Division of the Department of Justice Chad A. Readler. “This resolution is a testament to our deep commitment to public health and our determination to hold accountable those whose conduct results in improper payments by the federal government.”

Under the terms of the settlement agreement, ECW and three of its founders (Chief Executive Officer Girish Navani, Chief Medical Officer Rajesh Dharampuriya, M.D., and Chief Operating Officer Mahesh Navani) are jointly and severally liable for the payment of $154,920,000 to the United States. Separately, Developer Jagan Vaithilingam will pay $50,000, and Project Managers Bryan Sequeira, and Robert Lynes will each pay $15,000.

As part of the settlement, ECW entered into a Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company’s EHR software. This innovative 5-year CIA requires, among other things, that ECW retain an Independent Software Quality Oversight Organization to assess ECW’s software quality control systems and provide written semi-annual reports to OIG and ECW documenting its reviews and recommendations. ECW must provide prompt notice to its customers of any safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks. The CIA also requires ECW to allow customers to obtain updated versions of their software free of charge and to give customers the option to have ECW transfer their data to another EHR software provider without penalties or service charges. ECW must also retain an Independent Review Organization to review ECW’s arrangements with health care providers to ensure compliance with the Anti-Kickback Statute.

“Electronic health records have the potential to improve the care provided to Medicare and Medicaid beneficiaries, but only if the information is accurate and accessible,” said Special Agent in Charge Phillip Coyne of HHS-OIG. “Those who engage in fraud that undermines the goals of EHR or puts patients at risk can expect a thorough investigation and strong remedial measures such as those in the novel and innovative Corporate Integrity Agreement in this case.”

The settlement with ECW resolves allegations in a lawsuit filed in the District of Vermont by Brendan Delaney, a software technician formerly employed by the New York City Division of Health Care Access and Improvement. The lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery. The Act also allows the government to intervene and take over the action, as it did in this case. As part of today’s resolution, Mr. Delaney will receive approximately $30 million.

This matter was jointly handled by Assistant United States Attorneys Owen C.J. Foster and Nikolas P. Kerest of the U.S. Attorney’s Office for the District of Vermont, Kelley Hauser and Edward Crooke of the Commercial Litigation Branch of the Civil Division, the HHS Office of Inspector General, and multiple HHS agencies and components.

The case is captioned United States ex rel. Delaney v. eClinialWorks LLC, 2:15-CV-00095-WKS (D. Vt.). The claims resolved by the settlement are allegations only, and there has been no determination of liability.
Wow. One has to wonder; how many other EHR vendors have been defrauding the ARRA/HITECH program by gaming their ONC Certs?
This irritates me personally. Back when I was in the HealthInsight REC, I served Meaningful Use client practices using 14 different EHR platforms:
Amazing Charts
Allscripts (MyWay and Professional)
Practice Fusion
Optum CareTracker
eClinicalWorks (eCW) alone was at least a 3rd of my book. Back during the prior DOQ-IT era, HealthInsight had sent me to Westborough to train on eCW, so it was the platform with which I was most familiar and adept. Good UX functionality and features (though the workflow paths to some of the MU compliance criteria were "too many clicks" -- albeit hardly unique to eCW).

During the 2014 Health 2.0 Conference, eCW CEO Girish Navani blew a bunch of smoke up my butt, telling me he wanted to sponsor my KHIT blog. Follow-up went nowhere with that. No doubt a good thing, in hindsight.

So, now eCW merely gets Double Secret Probation and a "hefty" fine. But they don't have to admit guilt (LOL, spare me) nor lose their ONC Certification.
"The claims resolved by the settlement are allegations only, and there has been no determination of liability."
Class-action lawsuit comprised of eCW users perhaps in their future? Will CMS attempt to claw back MU incentive funds paid to eCW attestors?

Are other EHR vendors pulling this kind of crap? The "paper charts are better" and anti-ONC, anti-regulatory "free markets uber alles" crowds are all over this CusterFluck.

Jacob Reider at THCB:
Is eClinicalWorks the Next Volkswagen?
From HealthcareIT News:
Concerned the eClinicalWorks fiasco could happen to your EHR? Take these steps now
From FierceHealthcare:
eClinicalWorks settlement hints at broader certification infractions throughout the EHR industry

As Adrian pointed out and with my previous blog post that was referenced, it’s not surprising that events such as this have occurred with this proprietary software with certification boondoggle. Other industries have recognized the immense value of open source and it’s all around us (just not with much fanfare). When will physicians recognize there is much in common to what we do in our profession and the intrinsic ethos of open source software (which does exactly that Dr Zwerling had suggested – having the code out in the open to review, improve with physician input?). This is not a novel concept and the only ones who can make a choice and break away from this proprietary with or without certification duopoly are the end users themselves – patients and physicians.

As others have pointed out in other related blog posts on this site, we can’t realistically go back to pen and paper. We also can’t turn back time to undo the damage and $$$ lost with MU. With our political climate, we can’t hope and wait for legislation to turn things around in the next few months or even years. It’s in our hands. The tools are there for us. It’s not a theoretical proposition. We need to seriously talk about the prospect of open source and for those that are unfamiliar with it, get immersed and get to know more about it. It costs nothing and you can try it out (HIE and One and NOSH) and start that conversation. These open source projects only thrive if a community supports it. To me, the key value propositions of a meaningful open source health project are better patient care with happier physicians like me who are back in the business of taking care of their patients. Just that simple.
- Michael Chen, MD
I'm not persuaded that Open Source applications (and I happily use Firefox, Thunderbird, and Filezilla, to cite just three), as effective as they can be generally, represent the HIT panacea (Wiki list of open source Health IT here). A bit of false dilemma there, IMO. I began my white collar career in the 80's writing (what would now be called) "apps" in a forensic-level environmental radioanalytical lab in Oak Ridge (e.g., here, pdf). While my work was "proprietary" (IT/ORL was a privately-held commercial lab) the comprehensive QA packages having to be thoroughly reviewed and signed off by my Sups (inclusive of SOPs, source code, RDBMS schema, logic flowcharts, and validation sample data) before any of my work could be put into production were routinely available to hordes of regulatory and client examiners. I've been audited right down to my rounding algorithms, frequently under adversarial conditions. I've long been a critic of the feebleness of the simplistic and toothless ONC cert program.

A prior comment (same thread) at THCB:
ONC policy is the root of the problem and has caused the general erosion of trust in federal health initiatives that we have today.

Certification is a poor substitute for sunshine. The reason we have cheating in Volkswagen or eCW is that software that impacts our health is not open source. However, the harm of secrecy is clearer when the software can produce a medical error directly rather than just statistically impact our health through environmental damage.

Certification institutionalizes the growing practice of making medicine itself proprietary and secret. Open source medical software, like medical knowledge itself, is safe and trusted because it’s open to peer review and has no economic incentive to hide bugs or to cheat. On the contrary, open source software creates the incentive for bugs and shortcuts to be publicized in the hope that they will be quickly fixed. This is how medicine works as well, where we understand the critical importance of reporting adverse events.

My colleague Michael Chen, MD has authored the New Open Source Health (NOSH) EHR that’s at the core of our HIE of One initiative. His comments about certification and ONC policy in April and our other posts before predicted the failure of confidence that we are seeing with eCW and ONC today:

ONC policy to protect proprietary EHRs by erecting a certification barrier to open source software is the root of the problem. As Michael notes, it’s also the root of the “information blocking” / interoperability problem we have. How many lives and hundreds of $Billions is that costing us? Adding more regulations by certifying more secret software will not solve the problem of trust. Our physicians need to be using tools that are open to inspection, free to teach, to share, and to improve. It’s medicine.
- Adrian Gropper, MD
All points well-taken. But, still, I have false dilemma reservations. And I'm a bit put off by Dr. Gropper's imputations of ONC ill will and "regulatory capture" ulterior motives.

BREAKING: The VA just selected Cerner for their new EHR system. So much for Open Source (VistA).


From HealthcareDIVE:
eClinicalWorks false claims settlement could kick off more EHR investigations

Dive Brief:
  • Legal experts believe the recent $155 million settlement with EHR vendor eClinicalWorks in a False Claims Act case may be the start of greater Department of Justice (DOJ) activity in the EHR field.
  • FierceHealthcare reported that eClinicalWorks isn’t the only vendor that has “taken liberties with certification criteria” and Healthcare IT News predicted DOJ will shine the light on other EHR vendors for false claims.
  • The DOJ obtained more than $4.7 billion in settlements and judgments from civil cases that involved the False Claims Act last fiscal year. The DOJ has averaged nearly $4 billion on False Claims Act cases since fiscal year 2009 and has collected $31.3 billion during that period...
What a mess.

More to come...