The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

The Final Rule for Meaningful Use Stage 2 has been released.  It is at this link (PDF).  It is a mere 672 pages in length, a quick read during one's evenings of leisure.

Here is, from page 18 verbatim, the scientific justification for the program.  The finest scientific methods were used to achieve these criteria in justification of spending of $15 billion of taxpayer money in "incentives" (probably a low estimate), not counting the additional hundreds of billions the buyers themselves will spend that is diverted from your healthcare to the IT sector:

3. Summary of Costs and Benefits

This final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act.

Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule. The total Federal cost of the Medicare and Medicaid EHR Incentive Programs between 2014 and 2019 is estimated to be $15.4 billion (these estimates include net payment adjustments for Medicare providers who do not achieve meaningful use in 2015 and subsequent years in the amount of $2.1 billion).

In this final rule we have not quantified the overall benefits to the industry, nor to EPs, eligible hospitals, or CAHs participating in the Medicare and Medicaid EHR Incentive Programs. Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited. 

Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs, including reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, increased patient safety, and reduced medical errors. There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs.

There's no truly robust evidence of generalizable benefit, no randomized trials, there's significant evidence to the contrary (that, incidentally, is deliberately being ignored), there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study here) that MU and "certification" do not address, there's a plethora of hair-raising defect reports from the only seller that reports such things, but CMS justifies the program with the line:

"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."

I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science.

I recommend NIH, NSF, FDA and all other research and regulatory agencies immediately adopt this rigorous HHS methodology (called the "NWB" methodology for "nonetheless we believe") in their professional pursuits and research grant approval processes.

-- SS

Divide by Zero: Weird Math in CMS Clinical Quality Measure (CQM) Criteria

From the CMS "Medicare Electronic Health Record (EHR) Incentive Program - ATTESTATION USER GUIDE For Eligible Professionals (EPs)" (warning: large PDF), page 41/64:

... Step 25 – Core Clinical Quality Measures (CQMs 1 of 3)

EPs must report calculated CQMs directly from their certified EHR technology as a requirement of the EHR Incentive Programs. Each EP must report on three core CQMs (or alternate core) and three additional quality measures. If one or more core CQMs is outside your scope of practice, you will have to report on an equal number of alternate core CQM(s).

If the denominator value for all three of the core CQMs is zero, an EP must report a zero denominator for all such core measures, and then must also report on all three alternate core CQMs.

If the denominator value for all three of the alternate core CQMs is also zero an EP still needs to report on three additional clinical quality measures. Zero is an acceptable denominator provided that this value was produced by certified EHR technology.

Now, while I had an "800" in the math section of the SAT, where I believed that a fraction with a denominator of zero had a value of either infinity or 'undefined', that was many moons ago. Perhaps my knowledge of mathematics is now obsolete...

Wait - I tried this simple program on an old Microsoft MS-DOS GWBASIC interpreter, ported ca. 1981 to the Intel 8086/88 from Bill Gates' original 8080-based MBASIC, that I have laying around on my PC:

10 INPUT X
20 LET Y=X/0
30 PRINT Y
40 END

and got this warning/error message, right from Bill Gates:

"Division by zero"

and the answer: 1.701412E+38 (infinity in the 8/16-bit world from where GWBASIC sprang).

So ... allow me to say I find CMS math just a bit puzzling.

Wait ... now I understand.

Infinite quality! :-)

But thank heavens the zero denominator is only accepted when produced by 'certified' health IT.

Uncertified health IT is liable to produce a denominator of "i" (that is, the square root of -1).

-- SS

Addendum: since I am not a government math genius, I checked with Wikipedia:

... A common fraction (also known as a vulgar fraction or simple fraction) is a rational number written as a/b or , where the integers a and b are called the numerator and the denominator, respectively.^[1] The numerator represents a number of equal parts and the denominator, which cannot be zero, indicates how many of those parts make up a unit or a whole.

-- SS

Addendum:

This post is partly satire. I was a day late for April 1 but...

-- SS

The Center for Medicare and Medicaid Services' Quiet Coziness with Wall Street

An article from the Project on Government Oversight (POGO) reveals a new aspect of the growing coziness between the US government and big corporations with obvious relevance to health care.

CMS' Coziness with Leaders of the "Capital Markets"

Here is the introduction and the example most relevant to health care:

Nearly a dozen senior staff at the Centers for Medicare and Medicaid Services (CMS), the giant agency that administers hundreds of billions in federal health care dollars, had been called to a meeting. After a discussion with five Wall Street professionals that lasted nearly two hours, one senior CMS analyst filed an ethics complaint that later went to the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS).

His beef: that a handful of deep-pocketed investors had won a private hearing to probe whether the agency would allow Medicare reimbursement for specific medical devices manufactured by companies in which they already held a stake or might put new money. The market for one device, already approved for Medicare, was rapidly heading toward $1 billion annually; the agency’s impending decision to reimburse competing devices could have major market impact, a shift potentially worth hundreds of millions of dollars.

'This meeting forced agency staff to redirect their attention toward a select group from Wall Street, when neither competing investors nor patient-oriented stakeholders were present,' the whistleblower told the Project On Government Oversight (POGO). 'They got to probe us for hours in private about what we planned to do and how we approached procedures for reimbursing medical devices, the mechanics and psychology of CMS decision-making, in general and with respect to these specific devices.'

The meeting was set up by a former CMS employee working for the Marwood Group, an asset manager that counsels big health-care industry investors, the whistleblower says. The firm’s president is Edward 'Ted' Kennedy Jr., son of the late Massachusetts senator and a major supporter of President Obama’s health care reforms, and includes Kennedy cousins Robert F. Kennedy, Jr. and Stephen E. Smith, Jr., as senior advisors. The firm’s website highlights its staff recruitment among Congressional aides, the Executive Office of the President and CMS. One CMS veteran who joined Marwood after the 2009 meeting with Wall Streeters is Barry Straub, the agency's former Chief Medical Officer, who is also an expert on Medicare reimbursement, the website says. A company spokesman had no comment.

A supervisor at CMS’s Coverage Advisory Group, which decides which services the agency will pay for, also helped organize the session with investors. The whistleblower says he was told by a supervisor that such get-togethers are 'a routine practice at CMS.' At the time, in 2009, CMS’s top administrator had an aide with the title, 'capital markets advisor,' tasked with tracking investment community activity in Washington and elsewhere.

At the investor meeting, Wall Streeters asked a range of questions 'about confidential CMS information.' The whistle blower says he does not believe they received illegal disclosures, though they peppered CMS analysts with queries about the agency’s decision-making process and other sensitive matters which, if answered, could have violated the law or related regulations that bar the sharing of internal deliberations and decisions.

The whistleblower first filed his complaint in April 2009. He was terminated in 2011 for being disloyal to the agency mission after he made a series of internal protests, including the objection to what he calls a pattern and practice of unfettered access to CMS staff by Wall Street investors. He says he is currently fighting his dismissal through all available legal and administrative channels.

Implications and Summary

As the POGO article put it,

CMS does have a set of 'Open Door' policies and affords a variety of avenues for public access. The disclosure of payments to physicians and teaching hospitals by pharmaceutical companies and other interests are required under President Obama’s health reform. In practice, however, the public, not to mention competing investors and stakeholders, rarely get the kind of information and insight available in meetings like the whistleblower described.

In general,

A balance is necessary between the danger of too much insider access, and imposing excessive limitations. Indeed, the biggest problem with special access for Wall Street insiders is not just that they seem to get meetings and acquire information that may be privileged and non-public, but that others, including other investors, do not get a crack at the same material.

The activities above have all the usual elements of excess corporate - government coziness.  These include enhanced access for corporate leaders beyond what any ordinary members of the public might achieve; the revolving door between government service and corporate leadership; the participation of well-connected inside the beltway types, etc, etc. 

It also includes the apparent formalization of representation of corporate interests, e.g., the "Capital Markets Advisor," with no parallel formalization of the public's or patients' interests.  Even more worrisome is that an effort to make this all less anechoic resulted in alleged intimidation of a whistle-blower.

So, let's see, CMS, the Center for Medicare and Medicaid Services, the US Department of Health and Human Services (DHHS) branch which controls the Medicare and Medicaid programs, the government run single-payer programs for the elderly, the disabled, and the poor, does not seem to be able to afford to figure out in-house how to pay physicians for specific services.  Instead, it has effectively farmed out this task to a private committee, the American Medical Association's RBRVS Update Committee (RUC).  As we have discussed many times, this obscure and secretive committee likely had a major role in structuring the financial incentives that favor procedures and disfavor primary care. leading to excess costs, declining access, and degrading quality.  However, CMS can afford to have a "Capital Markets Adviser" and to use up staff time briefing wealthy investors and hedge fund types.  What is wrong with this picture?

In my humble opinion, government health care agencies ought to put the public's and patient's health first. They should not give special consideration to the rich, the powerful, the well-connected, whom some now call the one percent. Yet in the US we seem to have an increasingly corporatist state in which government and the plutocrats work together for their mutual interests, regulatory capture writ large.

We need to restore government, and our health care agencies to being of the people, by the people, and for the people.  Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.

Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an AMIA announcement:

CMS Innovation Center Announces $1 Billion Funding Opportunity:

CMS announced a new initiative, the Health Care Innovation Challenge, which will provide grants for new ideas to improve care and lower costs for those in Medicare, Medicaid and CHIP. CMS will award up to $1 billion in grants for a 3 year period and is encouraging providers, payers, local government, public-private partnerships and multi-payer collaboratives to develop new and innovative ways to improve care. To learn more about the grants and application process, check out the CMS Innovation Center website and be sure to register for the CMS webinar on Thursday.

CMS, I have an idea!

It's a really, really novel idea!

"Let's regulate HIT to improve its safety, usability, usefulness, fitness for purpose, effectiveness, etc." ™

That will lower healthcare costs! Save lives, too!

----------------------------------

Can I have my Billion Dollars now?

You can do a lot in health IT with a billion dollars - if you're not the HIT industry, that is, that has squandered a large wad of these over the past several decades.

-- SS

Another Blow to the Health IT Idealists: Sony CEO Howard Stringer, and HHS OIG, on Information Security

In a series of Healthcare Renewal posts such as those linked below, I pointed out that healthcare IT information security was largely a pipe dream, and that plans to create a national network of health information, while a seductive idea dating to the beginnings of computer networking, is not a good idea now.

• "Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?",

• "Networked, Interoperable, Secure National Medical Records a Castle in the Sky?",

• "Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?",

• "Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts",

• "Insurers Test Data Profiles to Identify Risky Clients",

• and others

Now you can hear it from another source: The CEO of one of the world's largest electronic companies, Sony.

Emphases mine:

Sony CEO Warns of 'Bad New World'
Wall Street Journal
May 8, 2011

TOKYO—After spending weeks to resolve a massive Internet security breach, Sony Corp. Chief Executive Howard Stringer said he can't guarantee the security of the company's videogame network or any other Web system in the "bad new world" of cybercrime.

Mr. Stringer's comments in a phone interview Tuesday, ahead of a New York roundtable discussion with reporters, come on the heels of a trying month for Sony. The company partially restored two of its online game systems and a streaming movie and music service over the weekend after shutting the services for several weeks when a breach compromised the personal information of more than 100 million account holders.

While Sony has restored part of the PlayStation Network—an online game system for its PlayStation 3 videogame console—in the U.S. and Europe and bolstered security measures, Mr. Stringer, 69 years old, said maintaining the service's security is a "never-ending process" and he doesn't know if anyone is "100% secure."

He said the security breach at PSN, Sony Online Entertainment, an online game service for personal-computer users, and its Qriocity streaming video and music network his company could lead the way to bigger problems well beyond Sony, or the gaming industry. He warned hackers may one day target the global financial system, the power grid or air-traffic control systems. [And healthcare, where identity theft, data alteration, and data destruction might occur - ed.]

I really don't think this is the time to be setting up a national health information network.

Beyond that, I offer no additional comments, other than that regarding the impossibility of keeping healthcare information secure on a national or even regional network, you may have heard it first here at Healthcare Renewal.

It would be prudent and consistent with the Hippocratic Oath to tone down our grandiose expectations and grandiose plans for these technologies in healthcare.

If you feel insecure yet, just wait a moment.

Going from very, very bad to very much worse:

An independent audit of ONC's and CMS's security programs by the HHS OIG (Office of the Inspector General) produced concerning if not alarming results to say the least:

Federal Audits Find HIT Security Problems at CMS, ONC
John Commins, for HealthLeaders Media
May 18, 2011

Audits of the federal agencies charged with implementing and monitoring security measures for healthcare information technology identified this week lax oversight and insufficient standards for healthcare providers.

The audits were conducted by the Department of Health and Human Services' Office of Inspector General, and targeted HIT security standards, privacy protection under HIPAA, and other security measures at the Centers for Medicare & Medicaid Services, and the Office of the National Coordinator. "These two reports are being issued simultaneously because OIG found weaknesses in the two HHS agencies entrusted with keeping sensitive patient records private and secure," OIG said in a media release.

The CMS audit, Nationwide Rollup Review of the Centers for Medicare & Medicaid Services Health Insurance Portability and Accountability Act of 1996 Oversight, examined seven hospitals across the country and found 151 "vulnerabilities" in systems and controls that are designed to safeguard electronic protected health information.

Those lapses included 124 "high impact vulnerabilities" such as unencrypted laptops and portable drives containing sensitive personal health information, outdated antivirus software and patches, unsecured networks, and the failure to detect rogue devices intruding on wireless networks, the OIG audit said.

"These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. Outsiders or employees at some hospitals could have accessed, and at one hospital did access, systems and beneficiaries' personal data and performed unauthorized acts without the hospitals' knowledge," the OIG audit said. "As a result, CMS had limited assurance that controls were in place and operating as intended to protect electronic protected health information, thereby leaving ePHI vulnerable to attack and compromise.

OIG's Audit of Information Technology Security Included in Health Information Technology Standards examined ONC's mandate under the HITECH Act to develop HIT security as part of a national HIT interoperability infrastructure. The audit found "no HIT standards that included general information IT security controls … which provide the structure, policies, and procedures that apply to a healthcare provider's overall computer operations, ensure the proper operation of information systems [which obviously also impacts patient safety - ed.], and create a secure environment for application systems and controls.

That's not very reassuring. In fact, it is downright frightening. ONC has to learn such lessons from HHS OIG? Read the whole thing.

I somewhat mordantly note that organizations such as ONC and CMS would probably never hire a person like me, who might actually kick-start true critical thinking on these issues. This is due to my non-bien pensant "bad attitudes", and lack of faith in cybernetic idols.

Click to enlarge. A well-known idol of gold. Computer circuits use gold, no?

-- SS