Buckshot: the continuing randomness of U.S. healthcare "value"

I've been doing summary reporting on selected annual HEDIS outcomes across the life of this blog. See my 2010,  2011, and 2012 posts (scroll down in any of them). A salient example from 2010:

HEDIS deploys two proxies which combine to connote value: "quality" (y axis) and "RRUs" (Relative Resource Units, the "cost" analog). As I observed in 2010,

Zero apparent linear "Pearson-R" relationship between cost and quality of outcomes (albeit via their summary "quality vs. cost" proxy scales). The foregoing plot addresses cardiovascular disease, but the scattergrams in the report illustrating other major chronic conditions (hypertension, diabetes, COPD) evince the very same random buckshot patterns. My red rectangle upper left quadrant annotation above is meant to focus on the question this begs of me: are we, consequently, paying too much? What is it about the "above average quality/below average cost" segment that we might discern were we able to "peel the onion back" in search of relevant causal correlates? Is use of HIT a factor? And/or other organizational factors? ( The NCQA report is silent on such implications).

Nothing has changed materially. Below, some selected scatterplots from the 2013 HEDIS Annual Report (pdf).

Groundhog Day. Payor doesn't matter. Major chronic dx doesn't matter. Buckshot.

Below, a graphic of a different (albeit related) sort. from the OECD 2013 report "Health at a Glance 2013."

The outlier U.S. Pay double, get less.
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NYeC 2013 Wrap-up

On November 14-15, NYeC held its third annual Digital Health Conference. This year’s conference was the biggest yet with more than 1100 attendees, 70 speakers, and 15 break-out sessions. Top level health IT professionals, CIOs, CMIOs, venture capitalists, entrepreneurs, academics, and a multitude of vendors gathered to discuss and learn about the latest thinking and innovation in the Health IT ecosystem. Two nationally-known experts on the power of data and analytics gave keynote addresses: George Halvorson, Chairman of Kaiser Permanente and Jim Messina, National Director of Organizing for Action and Campaign Manager for President Obama's re-election campaign. Both provided provocative and unique insights on the power of data analytics to significantly improve patient care and transform care delivery.

Hot discussion topics at the conference included HIE trends, the importance of interoperability standards on driving Health IT innovation, and the value of empowering consumers with their own health information as a tool to advance healthcare.

Thanks to all of our sponsors, partners, and speakers who helped to make this year's Digital Health Conference a resounding success.

LOL. There I am, front row in the Grand Ballroom at 1:52, blogging away into my Mac Air.

SELECTED NYeC DHC 2013 SLIDE DECKS

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More to come...

Oops

Yeah, charitably, we know what was intended. But, really? FORBES.com?

That little graphical y-axis faux pas aside, I wouldn't get all that worked up over a relatively weak apparent Pearson-R associated with the depicted U.S. "outlier-censored" linear trend line. I'd want to see median vs "average," for one thing. Yeah, spend more, live longer, of course.

Loosely. But, I'd drill down deeper (and I'm sure others are doing so).

Not to dismiss the obvious fact the we are not getting our money's worth here, in the U.S. overall. We know that (empirically if not polemically).
to wit

Having just finished contributing to a CMMI "Innovations Challenge" proposal having to do with care coordination via "health coaching" (see my January 8th post), I ran across a cautionary CBO report "Lessons from Medicare’s Demonstration Projects on Disease Management, Care Coordination, and Value-Based Payment" (PDF).

Forthwith, John Goodman PhD posted this on The Health Care Blog: "Why The Pilot Programs Failed"

"Failed?" Dr. Goodman's summary:

• On average, the 34 programs had little or no effect on hospital admissions.
• In nearly every program, spending was either unchanged or increased relative to the spending that would have occurred in the absence of the program.

Love this one: "spending was either unchanged or increased relative to the spending that would have occurred in the absence of the program."
Would have occurred? Rather speculative, that one.

OK. Here's the main graph from the CBO report.

So, on cost-containment and acute inpatient re-admissions, the various programs comprised ~ a net wash, with a rather large +/- distribution around the wash. Thought experiment; imagine a vertical center line in the bar graph. Push the image over, and see it as 3-D.

To me the above graphic is conceptually the equivalent of the findings of HEDIS data (regarding which I've written before), e.g.,


At the risk of nominally conflating "apples" with "oranges," it appears that we have long demonstrated ~zero "cost vs quality" for quite some time, no matter what we try, no matter what proxy correlative metrics we proffer, no matter who the payor (like we didn't already know that). But, I want to know what the respondents in the upper left quadrant of the HEDIS graphic (representative of all of the major Chronics, btw) are doing right within the overall shotgun scatter. Similarly, I'd want to study further the "successes" part of the "Pilot Programs."

Spin as "failure"? To just summarily frame an evaluation as "Why The Pilot Programs Failed" could not be more transparently partisan. Perfectionism Fallacy 101 (one which conveniently ignores the pesky fact that most private sector bootstrap or VC-funded initiatives also "fail" in one way or another).

SO, WHAT'S THE CONNECTION?

I don't think anyone intends that we do the same thing over and over. For example, a core component of HealthInsight's grant proposal -- in addition to that of "health coaching" for patient self-management support -- is that of "clinic coaching," i.e., workflow analysis and re-design training for clinic staffs, with a specific emphasis on optimizing HIT use, through which to improve care and outcomes while reducing the FTE burden of HIT use. This maps right to the observations made by Messrs Weed in "Medicine in Denial" (we will head back Down in the Weeds' shortly).

APROPOS

ONC: Health apps among big trends of 2012
By: Brian Dolan | Jan 30, 2012 Last week Dr. Farzad Mostashari, the National Coordinator for Health Information Technology at the US Department of Health and Human Services, penned a column on his top five health IT predictions for the year ahead. Not surprisingly, Mostashari expects consumers to use eHealth to get more involved in managing their own health. “I believe this year we will see consumers and patients use information technology to become better informed about their health and more engaged with their own care than ever before,” Mostashari writes. “In large part, this will happen because it’s becoming easier for consumers to electronically access their own information. Personal health records are becoming easier to use as more data holders make it possible to download information through tools like Blue Button. Many health care providers are setting up patient portals which are directly connected to their EHRs. The Medicare and Medicaid EHR Incentive Programs already require providers to give patients access to their electronic health information, and I anticipate future stages will build on that notion. And the work that is being done on standards and interoperability will help make consumer access to their health information more seamless and more useful.” Mostashari also noted his office’s push to encourage developers to create more meaningful health apps through its series of app challenges that it puts on through Health 2.0, which received a $6 million grant to conduct the challenges. “In addition, developers are coming out with more apps for mobile devices that make it easier for consumers and patients to get information about different diseases and track their own health over time. Along those lines, several Beacon Communities have launched txt4health, a consumer engagement campaign that uses cell phone text messaging to deliver information about diabetes care and management,” Mostashari writes. “ONC will diligently keep encouraging the marketplace to develop mobile apps and other consumer-friendly platforms that get patients engaged by sponsoring challenges like the Healthy Apps Challenge. Once consumers start to see their own information, they will be more empowered to be partners in their own care and come to expect that providers will use health IT as a tool to help deliver high-quality care.”...

Yeah, but, a lot of this "innovations" stuff has distinct vestigial wafts of the Dot.com era of a decade ago.


As I recently observed in the comments in "The Entrepreneur’s Dilemma," why, it's


More thoughts on this shortly, which, for one thing, is gonna take me Back Down in the Weeds'...
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ANOTHER MINOR "OOPS"

So, I got to this link in the wake of reading a couple of articles on health care at Forbes.com

Yeah! Yet another "innovation" effort, I guess, this one by Forbes contributor Dan Munro. So, we're just supposed to summarily "recommend," "tweet," or "invite" without knowing any details? "Share the news"? WHAT "news"?

I clicked on "Like Us on Facebook" to perhaps learn more.

Only to get this.

Whatever. In fairness, their "blog" link works.

CODA

Dr. Kent Bottles reports on the recent CMS Care Innovations Summit over at The Health Care Blog.

PS- one more "Oopsey" for your HIT enjoyment:

The twisty politics of HIT

..."Shortly before the passage of the 2009 federal economic stimulus package, Gingrich criticized the legislation as a "big politician, big bureaucracy, pork-laden bill." However, at the same time, Gingrich praised a provision of the stimulus package that allocated $19 billion to promote the use of health IT. He said, "I am delighted that President Obama has picked this as a key part of the stimulus package."

Under the stimulus package, health care providers who demonstrate meaningful use of certified electronic health records can qualify for Medicaid and Medicare incentive payments...

"I am delighted that President Obama has picked this as a key part of the stimulus package."

Right, Mr. Gingrich. Insofar as it was then politically convenient, 'eh? (Click here or the image above for the link.)

Apropos of the forgoing. Monday morning news:

...Regulatory pressure is building on the industry to achieve the goals of Presidents George W. Bush and Barack Obama to provide most Americans with access to an electronic medical record by 2014. An early fissure as a result of that pressure comes as Dr. Farzad Mostashari, head of the Office of the National Coordinator for Health Information Technology, supports a federal advisory committee's recommendation in June that the CMS extend by one year the compliance deadline for Stage 2 meaningful use for some early adopters of health information technology...

Once we get the total head count and subsequent relative proportions of "early adopters" (those who attested in 2011), we'll have a better picture of how this all might shake out going forward. Pushing back Stage 2 was a good and necessary idea, IMO.

Also noteworthy in the Modern Healthcare article:

Breaches and privacy lapses make headlines again in 2011 as healthcare organizations suffer record data losses during the year. In September, in its report to Congress, the Office for Civil Rights at HHS says there have been more than 30,500 breaches, most with fewer than 500 records, since it began counting them in late 2009. By year's end, the office's public “wall of shame” lists 372 major breaches (involving 500 or more records each) totaling nearly 18 million records. Military healthcare payer Tricare Management Activity and its data backup services vendor, Science Application International Corp., tops the wall with the largest breach of the year at 4.9 million records.

I guess as the penetration of HIT increases, we should expect an increase in PHI breach incidents. Which brings to mind the following (click to enlarge):

HIPAA Security Rule Toolkit

The NIST HIPAA Security Toolkit Application is intended to help organizations better understand the requirements of the HIPAA Security Rule, implement those requirements, and assess those implementations in their operational environment. Target users include, but are not limited to, HIPAA covered entities, business associates, and other organizations such as those providing HIPAA Security Rule implementation, assessment, and compliance services. Target user organizations can range in size from large nationwide health plans with vast information technology (IT) resources to small health care providers with limited access to IT expertise...

I've installed it and have been kicking the tires. 492 questions (some of them conjunctive clause compound questions) spanning the gamut of 45 CFR 164.3. More on this shortly.
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DEC 19th P.M. UPDATE

The NIST HIPAA toolkit is a bear. Lots of compound questions, e.g., the first 13 questions:

164.308(a)(1)(i) Standard: Security management process. Implement policies and procedures to prevent, detect, contain, and correct security violations.

1. Has your organization developed, disseminated, reviewed/updated, and trained on your Risk Assessment policies and procedures?
2. Does your organization's risk assessment policy address: purpose, scope, roles and responsibilities management commitment, coordination among organizational entities, training and compliance?
3. Has your organization disseminated your Risk Assessment policies and procedures?
4. Has your organization disseminated its Risk Assessment procedures to the work staff/offices with the associated roles and responsibilities?
5. Has your organization defined the frequency of your Risk Assessment policy and procedures reviews and updates?
6. Has your organization reviewed and updated your Risk Assessment policy and procedures in accordance with your defined frequency?
7. Has your organization identified the types of information and uses of that information and the sensitivity of each type of information been evaluated (also link to FIPS 199 and SP 800-60 for more on categorization of sensitivity levels)?
8. Has your organization identified all information systems that house ePHI?
9. Does your organization inventory include all hardware and software that are used to collect, store, process, or transmit ePHI, including excel spreadsheets, word tables, and other like data storage?
10. Are all the hardware and software for which your organization is responsible periodically inventoried, including excel spreadsheets, word tables, and other like data storage?
11. Has your organization identified all hardware and software that maintains or transmits ePHI, including excel spreadsheets, word tables, and other similar data storage and included it in your inventory?
12. Does your organization's inventory include removable media, remote access devices, and mobile devices?
13. Is the current information system configuration documented, including connections to other systems, both inside and outside your firewall?

OK, and then the last section, first subsection:

164.316 POLICES AND PROCEDURES AND DOCUMENTATION REQUIREMENTS

164.316(a) Standard: Policies and procedures. Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in subsection

164.306(b)(2)(i), (ii), (iii), and (iv). This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart. A covered entity may change its policies and procedures at any time, provided that the changes are documented and are implemented in accordance with this subpart

1. Does your organization have policies and procedures for administrative safeguards, physical safeguards, and technical safeguards?
2. Does your organization have in place reasonable and appropriate policies and procedures that comply with the standards and implementation specifications of the HIPAA Security Rule?
3. Does your organizations security policies and procedures take into consideration: 1) your organization's size, complexity and the services you provide. 2) your organization's technical infrastructure, hardware and software capabilities, 3) the cost of your organization's security measures, 4) the potential risks to day-to-day operation including which functions, and tools are critical to operations?
4. Does your organization have procedures for periodic revaluation of your security policies and procedures, and update them when necessary?
5. Does your organization change security policies and procedures at any appropriate time, and document the changes and implementation?

My take on this is that it would take a provider/organization 2-5 days to get thoroughly and forthrightly through it. And, really, this is just about the ePHI "Security" piece. "Privacy" is a different -- and potentially much more difficult -- issue. I wrote about the Security stuff back in June, and I continue to work on the privacy issues more recently for our HIE.
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MEANINGFUL USE CORE 15:
WHAT ARE YOU PEOPLE THINKING?


So, my wife and I are devoted Mac snobs at home. Consequently, I was thrilled to recently see an iPad app get certified for meaningful use.

The product looks great, and I'll bet it's quite functional.


HOWEVER...

I was not happy to see this regarding the Meaningful Use Core 15 criterion ("Protect Electronic Health Information"):

We've taken care of this one for you!

All of the items below are done automatically through drchrono.com (web) drchrono EHR (iPad)

Access Control: Each user must have a unique identifier. Assign a unique name and/or number for identifying and tracking user identity and establish controls that permit only authorized users to access electronic health information. §170.302(o)

Emergency access: Plan for emergency access for authorized users. Emergency access. Permit authorized users (who are authorized for emergency situations) to access electronic health information during an emergency. §170.302(p)

Automatic log-off: Turn on session timeouts.

Automatic log-off: Terminate an electronic session after a pre-determined time of inactivity. §170.302(q)

Audit log: Maintain audit logs.
(1) Record actions. Record actions related to electronic health information in accordance with the standard specified in §170.210(b).
(2) Generate audit log. Enable a user to generate an audit log for a specific time period and to sort entries in the audit log according to any of the elements specified in the standard at 170.210(b).

Integrity - Provide integrity check for recipient of electronically transmitted information. §170.302(s)
(1) Create a message digest in accordance with the standard specified in 170.210(c).
(2) Verify in accordance with the standard specified in 170.210(c) upon receipt of electronically exchanged health information that such information has not been altered.
(3) Detection. Detect the alteration of audit logs.

Authentication - Verify user identities and access privileges. Verify that a person or entity seeking access to electronic health information is the one claimed and is authorized to access such information. §170.302(t)

Encryption - Use encryption where preferred. §170.302(u) General encryption. Encrypt and decrypt electronic health information in accordance with the standard specified in §170.210(a)(1), unless the Secretary determines that the use of such algorithm would pose a significant security risk for Certified EHR Technology. §170.302(v) Encryption when exchanging electronic health information. Encrypt and decrypt electronic health information when exchanged in accordance with the standard specified in §170.210(a)(2).

Accounting of disclosures - Record PHI disclosures. §170.302(v) Record disclosures made for treatment, payment, and health care operations in accordance with the standard specified in §170.210(e).

Conduct a security risk analysis and implement security updates.

Gotta love the last little orphan sentence. OK, everything associated with §170.nn has to do with the NIST EHR Certification specs, and nothing to do with complying with MU Core Measure 15:

Conduct or review a security risk analysis per 45 CFR 164.308(a)(1) of the certified EHR technology, and implement security updates and correct identified security deficiencies as part of its risk management process.

Beyond having a CHPL blessed system, it's the last item that counts for MU.

I emailed them regarding this and gave them more than a week. Silencio. Nada. Zip. Zilch.

This is not the first time I've encountered this precise misinformation from an EHR vendor.

So, what if you got audited? "Well, they told us we were automatically in compliance..."

"Conduct or review a security risk analysis per 45 CFR 164.308(a)(1) of the certified EHR technology, and implement security updates and correct identified security deficiencies."

So, who cares?

Digital Data on Patients Raises Risk of Breaches
By NICOLE PERLROTH
NY Times. Published: December 18, 2011

One afternoon last spring, Micky Tripathi received a panicked call from an employee. Someone had broken into his car and stolen his briefcase and company laptop along with it.

So began a nightmare that cost Mr. Tripathi’s small nonprofit health consultancy nearly $300,000 in legal, private investigation, credit monitoring and media consultancy fees. Not to mention 600 hours dealing with the fallout and the intangible cost of repairing the reputational damage that followed...

Shall we tally up an estimate of the entire cost of not having corrected "identified security deficiencies" per HIPAA 45.CFR.164.3 et seq?
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ERRATA: HEDIS 2011 THOUGHTS


I blogged a bit about the 2010 HEDIS measures last year. I've been reading the 2011 report lately. Notwithstanding the new stratification of HMOs vs PPOs (and vs Medicaid as well), I can't really see that a whole lot has changed with respect to the major chronic indices. e.g.,

Overall, we still see the aggregate nil Pearson-R "quality vs cost" proxies' scatter. And, even where there are enticing (wish-fulfillment?) wafts of quadrant differentials, the small composite "N's" ought give one pause.

Maybe we'll make tangible progress on these fronts in the next few years (we must if we are not to go BK as a society). IMO there are two concomitant (and intertwined) "fronts" -- care delivery process improvements (X-axis) and clinical outcomes improvement (Y-axis). The latter of which is to a significant extent moreso a moving target.

"Value," my friends: Outcomes Quality / Cost. Hope it doesn't become this decade's Powerpoint / Seminar / Consulting / Book Sales cliche. (But, then, They Had Me at Deming.)
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12/11 "PIONEER ACO" announcement

Interesting. Healthcare Partners of Nevada is one of the 32 announced today. We already work with them via our new HIE.

CMS MEANINGFUL USE PAYMENTS UPDATE

I played around a bit today with an app free trial that converts PDF tables to Excel files. CMS has updated its payments-to-date data (it says "November 2011" but it's not clear whether it's begin or end of month), so I downloaded the new PDF and converted it (click to enlarge).


I added the 4 "pct" columns on the right, and sorted the data down by aggregate payment rank. The top 12 states account for 2/3 of the money. Texas, with ~8% of U.S. population, is now at 16.4% of the cash -- and nearly 3/4 of theirs is Medicaid.

Be fun to also drop in the Census data to do comparative "per capita."

We'll see how all of the Medicaid Year One "A/I/U" free money crowd does in 2012 when they have to actually meet the MU criteria, for an entire calendar year attestation.

They have other tables that break things out by EPs vs Hospitals (Medicare, Medicaid, and aggregate), which would tell us where the bulk of the money is going vis a vis those strata (like we don't already know).

I may buy that utility -- if they have a Mac version.
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MORE TWISTY POLITICS:
THE LOOMING MEDICARE REIMBURSEMENT CUTS

27.4% reduction ensues on January first absent Congress passing the "Doc Fix" in the tax cut renewal bill. The health press is fairly abuzz.


Another quick little Excel screen-scrap cut & paste. The 2012 estimate is mine for these two CPT codes, btw. Just an estimate. The whole Medicare SGR formulation is inscrutably complex (and uniformly hated by primary care docs).

Who will blink first, Boehner or Obama?
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HOLIDAY CODA

I'm off 'til the 30th. To all of my awesome REC colleagues (both within our office walls and across the RECs), I wish you a joyful and safe Holiday season.

My dear friend, the breathtakingly talented Lenny Lopez on vocal.

Mulligan: 7.5 months into my REC adventure

I was re-hired on March 2nd by HealthInsight for the REC initiative. Been a most intense, interesting, and at times sleep-deprivingly frustrating experience. I have a number of developments and concerns on which to report. I started this post on September 3rd, but my heavy work and travel schedule and a bout of illness have necessitated a Mulligan. So, here we go again.

As with most of my blogging, this will necessarily be incremental as time permits, as this is a personal, assiduously off-the-clock independent project (albeit rather unloved by one of my Sups nonetheless) in support of the REC effort.

Among other things, I will reflect on my experience at the recent Salt Lake City REC Regional ONC Conference, the subsequent inaugural (sparsely attended) "Digital Medical Office of the Future Conference" in Las Vegas, the interesting October 12th Nevada Health Care Forum 2010, as well policy developments in the wake of the release of the 864 page Stage One Meaningful Use Final Rule and the subsequent announcements of both the release of NIST test specifications for ARRA Certification of EHR systems and the first two Certification Registrars -- CCHIT and The Drummond Group (I believe there is now a 3rd Registrar in place as well).

First...


You ought read this timely, excellent piece ever so closely, yellow highlighter and red pen at the ready (click the title image above for a PDF copy). A couple of takeaways: While everyone is focally anguishing over the intensified HIPAA privacy and security implications of HIT going forward, this legal writer (a medical liability attorney) points out that

• routine use of HIT (inclusive of both EHR and HIE) will likely become an integral part of accepted legal "standards of care," e.g., "it seems logical that a liability inquiry will turn to how information technology has been used by clinicians and whether that use itself comports with the standard of care for maintaining and using medical records."
• relatedly, issues of data accuracy, security (specifically with respect to inadvertent or intentional data corruption), and retention for "E-Discovery" are likely to find their way into court (including issues relating to the net probative value of the soon-to-be-mandatory always-on "audit logs" in certified EHR systems).
  

Calls continue for FDA regulation of EHRs as de facto "medical devices," and there are now legislative stirrings for mandating EHR use a condition of medical licensure.

"...from the health care law and medical liability perspective, EHRs mark a fundamental shift in how we use and collect electronic medical evidence, as well as what we must think about when anticipating health care litigation."

A lot to consider here. Download it and read it carefully.
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BTW, I'd like to give an unsolicited shout-out to fellow (literally neighboring) HIT blogger John Lynn. I check his blogs every day (among the numerous others within which I routinely lurk), and comment there regularly in the spirit of engaging constructive dialogue. Click the images below for direct links (they're also in my "Links" column on the right).


Also: The NIST EHR Certification test SOPs:

There are 46 SOPs, addressing the full range of Meaningful Use criteria across outpatient and inpatient settings, e.g.,

§170.302 (g) Smoking status. Enable a user to electronically record, modify, and retrieve the smoking status of a patient. Smoking status types must include: current every day smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown; unknown if ever smoked.

The standard here is silent on exactly how the options are to be presented to the EHR user. Mutually exclusive "radio buttons"? A drop-down menu choice list? (It is also silent on the underlying data structure -- which I would assume to be mostly SQL RDBMS tables. The entries could be stored literally as text strings [all lower case, as per the std?], or they could be recorded in binary 0/1 integer fields mapped to the "human-readable structured data" responses a user sees on the screen or in a printed report?)

One could also interpret this standard to mean that some pre- ONC certification EHRs already comply, with no upgrade revision necessary for this particularly criterion. See, for example, a screen shot I clipped of the current release of e-MDs:

One could, I suppose, manually (or via a macro) enter "current every day smoker" or one of the MU-requisite forced-choice alternatives into this catch-all "Tobacco/Alcohol/Supplements" free-text box.

Cleanly and efficiently tabulating/reporting the data back out, however, would likely be a mess. Let us count the ways user could (and would) misspell these.

One more example:

§170.302 (h) Incorporate laboratory test results.

1) Receive results. Electronically receive clinical laboratory test results in a structured format and display such results in human readable format.

2) Display test report information. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7).

3) Incorporate results. Electronically attribute, associate, or link a laboratory test result to a laboratory order or patient record.

A question arose recently regarding lab findings that typically come back in as simply "positive" or "negative" (or "POS"/"NEG") or, equivalently, "present" or "not found/not present" etc text. Again, the standard is silent, in that the specified "test data sets" all simply provide numeric lab values for the variety of assay parameters the EHR must be able to replicate for certification.

The phrase "human-readable structured data," it should be apparent, goes beyond numeric values, and the standard does not address this.

[BTW: It should be noted that not all of the MU criteria involve capturing numerator data in the EHRs for subsequent reporting. e.g., §170.302(a) Drug-drug, drug-allergy interaction checks, §170.302(o) Access Control, §170.302(p) Emergency Access, §170.302(q) Automatic Log-off, §170.302(r) Audit Log, etc. Just to observe that, for the criteria that do involve numerator/denominator data, effective analysis and reporting assume uniform data input, as no one in clinical settings is likely going to have time or inclination to to any post-hoc "data cleaning."]

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AUGUST ONC REGIONAL CONFERENCE IN SALT LAKE CITY

The final of five 2010 ONC regional meetings. I was struck by the large number of very young (to me) ONC staffers, an ebullient, brash cadre of ambitious MBAs and MPHs mostly, full of evangelistic energy and smarts (but most of them relatively short on direct operational HIT experience). I wanted to card some of these people during the evening open bar reception.

It was very well attended, and very busy; a packed agenda, the most contentious of which was the "Meaningful Use Deep Dive" session. A harbinger of the frequently inscrutable, vexing interpretations of the Meaningful Use criteria that continue to this day. At our REC we continue to hold bi-monthly Meaningful Use Study Group teleconference sessions to help us clarify issues as they emerge during interaction with our providers.

One fun activity during the Plenary Session: "Meaningful Use Jeopardy," LOL.

Your tax dollars at work. They did a good job with this, I have to say. The questions spanned the gamut, and were often very tough. My HealthInsight REC tied for first place.

One of the principal ONC operatives present was Thomas Tsang, M.D., M.P.H., Medical Director, Meaningful Use. I approached him during an intermission to ask why the RECs had not been made mandatory as part of the legislation (regarding which he'd been involved in drafting), lamenting that we were burning up a lot of FTE "marketing" our federally subsidized services, in lieu of focusing on actual technical assistance activities -- that it opened the administration up to the criticism of just wildly throwing money at the problem at cross-purposes.

He ever so politely blew me off, responding that "you are federal grantees, you are not part of the federal government."

Right. Well, my very same not-for-profit federal contractor company is also the NV-UT Medicare QIO, and our QA/beneficiary protection "statutory side," while equally "not [directly] part of the federal government" is nonetheless mandatory for providers who serve Medicare beneficiaries. You provide medical services to Medicare benes, you will submit to QIO statutory review purview, period.

I dropped the line of inquiry. He obviously didn't want to hear it, and it was moot by now in any event.

THE WORKFLOW SESSION

The MassPro QIO people led this session. It was very good, though much of the material struck me as "warmed-over DOQ-IT" (the now discontinued CMS HIT initiative within I which I worked during 2005-2007). My concern here is that both the ends and the scale of the Meaningful Use program require a significant re-thinking of the "adoption support" workflow M.O.

Notwithstanding, one has to give MassPro credit for sharing their considerable experience and expertise.
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The HITRC

When I began this blog series, I noted that the Health IT Research Center, "whose purpose is to gather relevant information on effective practices from a wide variety of sources across the country and help the Regional Extension Centers (RECs) collaborate with one another and with relevant stakeholders to identify and share best practices in EHR adoption, effective use, and provider support" was not slated to be in place until FY 2012. Happily, though, I can report that this online resource is in fact now up and running, with REC staff nationwide contributing and sharing tools and ideas.

Not without bursts of silliness here and there, though. Some REC folks have had the earnest idea of doing "SWOT analysis" on the Meaningful Use criteria themselves. This is what ensues, I suppose, when MBAs go unsupervised. SWOT analysis is a tactical tool for assessing the competitive characteristics of organizations.

How about mere "pros and cons," folks? To me, this is somewhat methodologically akin to calculating Likert Scale data out to four decimal places (and then maybe even doing regression analyses on them, just because Excel makes it so easy).

Another bit of puzzlement. Someone enthusiastically posted to the HITRC regarding the nascent "ONC branding logo." I quickly grabbed the image and merged it with our corporate logo for a quick bit of Photoshop "co-branding" imagery (at the request of my Sup)...

Only to be subsequently informed that the ONC logo was not yet available for REC use, as it was still "undergoing the trademarking process."

A taxpayer-funded graphic. "Trademarked"?

Legalistic "ownership" and "use in commerce" hair-splitting aside, why not just slap the common law "TM" on it and put it to use? Awaiting granting of a "registered" ® symbol seems pointless, given the typical long timeline (not to mention the expense) of that process. A good number of RECs may well have folded their tents by "® Day."

Whatever. Your tax dollars at work.
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SEPTEMBER:
THE INAUGURAL "DIGITAL MEDICAL OFFICE THE THE FUTURE" CONFERENCE.

Well, can you say "underwhelming"?

They gave us 40 comps. Telling, right there, I suppose. Obviously, they hoped we'd spread them around to our REC client and prospect providers. A tough sell here in southern Nevada, asking marginally viable docs to give up a couple of days of billable visits to come and hear yet more rah-rah about the virtues of HIT.

When I arrived and looked in the attendee packet, there was a total of 88 people on the attendee list -- seven of which were us (from HealthInsight). The total actual body count was more like 60 or so. As I ambled about the expansive lower-level conference center of Green Vally Ranch, the quietude evoked scenes from "The Shining."

It was during this conference that I got my first taste of the overt vested-commercial-interest REC-bashing that has ensued. A presenter, who was also a presentation track chair (a private EHR consultant whom I will not name), launched into his session with an inappropriate slide deriding the "Socialist" federal HIT program, whereafter he went on to mischaracterize the RECs as all "choosing the EHRS" for their REC provider clients and all "driving doctors toward SaaS model platforms" (web-based EHRs). His presentation also inappropriately gave ample play to his own EHR evaluation website and newsletter and books.

I had to bite my tongue.
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REC BASHING

It picked up steam here, in an online article entitled "Five Reasons We Think RECs are RECkless," written by one Houston Neal, a person with no apparent experience in HIT (I emailed him to ask. He deflected with a vague non-answer, while at the same time having the amazing chutzpah to ask me if I'd have his derogatory article linked on our HealthInsight website).

His summary allegation:

In our opinion, there are five fundamental flaws with RECs:

1. Doctor’s [sic] aren’t moving as fast as the money is flowing
2. The market already delivers on what RECs promise
3. “Preferred vendor lists” limit choice and free markets
4. RECs won’t get doctors to “meaningful use” fast enough
5. The REC model leads to under-staffed, ephemeral entities

Anyone who has troubled themselves to fully read my REC blog to date has to admit -- if honest -- that I am no Pollyana REC cheerleader, but, this this stuff is loaded down with dilettante and ulterior motive Straw Men. I cannot speak for every REC, but I bristle at the broad-brush assertion that we are all under- and otherwise inadequately staffed, that we don't deliver any value not already available via the commercial consultant market (that is patently absurd), and that we are all "limiting choice" via "preferred vendor lists" (HealthInsight is assiduously vendor neutral). Moreover, that the docs may not be moving as fast as the money and the MU deadlines is certainly not of our doing. We have play the hand we were dealt.

Finally, with respect to the "RECs can't compete with the private market for HIT talent" assertion, let me just observe that when I went through the HealthInsight re-hiring process, I was one of several hundred candidates.

Unhappily, this article got rather wide and mostly uncritical play (e.g., at The Health Care Blog and on one of my friend John Lynn's blogs). Like we need more sand in the gears (and, again, not to assert that we are above criticism).
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OCTOBER:
THE NEVADA HEALTH CARE FORUM

Policy. Gets my juices flowing (my grad degree is in "Ethics and Policy Studies"). While I was not re-hired by HealthInsight for my policy chops (I'm a technical assistance project coordinator), it's nonetheless in my blood, and I was gratified to attend this event, which was all about a breadth of policy issues as they bear on the fiscally ailing state of Nevada. Our CEO Marc Bennett served on a discussion panel, and, to me, he was the most astute person on the podium that day (and I am not sucking up, either, we have very little contact, notwithstanding that I have known him since 1993).

One upshot of my attending was my being invited to present on Nov 18th statewide via live audience and teleconference to the Nevada Chapter of the Health Care Financial Management Association on the subject of health policy reform, about which I've written rather extensively, e.g.,

• The U.S. health care policy morass
• Doing some basic health care reform math
• BREAKING: Foreign born Radical Communist Obama wants to kill Grandma and Grandpa
• Public Optional
• Irrespective of national health care policy reform legislation, the medical sector is going full-steam-ahead HITECH
  
  

Should be fun. One question I will pose goes to the implications of this image from the recently-released 2010 NCQA HEDIS-based report.

Zero apparent linear "Pearson-R" relationship between cost and quality of outcomes (albeit via their summary "quality vs. cost" proxy scales). The foregoing plot addresses cardiovascular disease, but the scattergrams in the report illustrating other major chronic conditions (hypertension, diabetes, COPD) evince the very same random buckshot patterns. My red rectangle upper left quadrant annotation above is meant to focus on the question this begs of me: are we, consequently, paying too much? What is it about the "above average quality/below average cost" segment that we might discern were we able to "peel the onion back" in search of relevant causal correlates? Is use of HIT a factor? And/or other organizational factors? ( The NCQA report is silent on such implications).

We have seen a similar kind of thing before, e.g.,

Evidence a decade ago of a weak inverse relationship (just a tad this side of purely random, unlike the NCQA/HEDIS data) between per capita Medicare expenditures and "quality ranking." Again, of interest to me analytically would be the lower cost/higher quality outcomes cohort.

I am again reminded of the words of Dr. Atul Gawande last year in "The Cost Conundrum" -

"Dramatic improvements and savings will take at least a decade. But a choice must be made. Whom do we want in charge of managing the full complexity of medical care? We can turn to insurers (whether public or private), which have proved repeatedly that they can’t do it. Or we can turn to the local medical communities, which have proved that they can. But we have to choose someone—because, in much of the country, no one is in charge. And the result is the most wasteful and the least sustainable health-care system in the world...

...In the sharpest economic downturn that our health system has faced in half a century, many people in medicine don’t see why they should do the hard work of organizing themselves in ways that reduce waste and improve quality if it means sacrificing revenue."

Indeed.

More to come...

NEW POST UPSTAIRS
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SPC for Lean Newbies

I noted my concern a couple of posts back that the Lean Healthcare Transformation Summit 2013 appeared to be way light on the technical detail issue of SPC (Statistical Process Control) as a core component of the PDSA cycle that is otherwise touted as the foundation for the Lean process.

PDSA should really be "SPDSA" -- Study, Plan, Do, Study, Act.

I guess it's implicit in the "Plan" part (study the current state and incorporate the findings into your Plan). But, I didn't see much evidence of the quantification imperative of that in Orlando.

In fairness, my cautionary dubiety about "Six Sigma" aside, the DMAIC people are on point here (props to the Wiki):

Define
The purpose of this step is to clearly articulate the business problem, goal, potential resources, project scope and high-level project timeline. This information is typically captured within project charter document. Write down what you currently know. Seek to clarify facts, set objectives and form the project team. Define the following:

• A problem statement
• The customer(s)
• Critical to Quality (CTQs) — what are the critical process outputs?
• The target process subject to DMAIC and other related business processes
• Project targets or goal
• Project boundaries or scope
• A project charter is often created and agreed upon during the Define step.

Measure
The purpose of this step is to objectively establish current baselines as the basis for improvement. This is a data collection step, the purpose of which is to establish process performance baselines. The performance metric baseline(s) from the Measure phase will be compared to the performance metric at the conclusion of the project to determine objectively whether significant improvement has been made. The team decides on what should be measured and how to measure it. It is usual for teams to invest a lot of effort into assessing the suitability of the proposed measurement systems. Good data is at the heart of the DMAIC process:

• Identify the gap between current and required performance.
• Collect data to create a process performance capability baseline for the project metric, that is, the process Y(s) (there may be more than one output).
• Assess the measurement system (for example, a gauge study) for adequate accuracy and precision.
• Establish a high level process flow baseline. Additional detail can be filled in later.

Analyze
The purpose of this step is to identify, validate and select root cause for elimination. A large number of potential root causes (process inputs, X) of the project problem are identified via root cause analysis (for example a fishbone diagram). The top 3-4 potential root causes are selected using multi-voting or other consensus tool for further validation. A data collection plan is created and data are collected to establish the relative contribution of each root causes to the project metric, Y. This process is repeated until "valid" root causes can be identified. Within Six Sigma, often complex analysis tools are used. However, it is acceptable to use basic tools if these are appropriate. Of the "validated" root causes, all or some can be

• List and prioritize potential causes of the problem
• Prioritize the root causes (key process inputs) to pursue in the Improve step
• Identify how the process inputs (Xs) affect the process outputs (Ys). Data is analyzed to understand the magnitude of contribution of each root cause, X, to the project metric, Y. Statistical tests using p-values accompanied by Histograms, Pareto charts, and line plots are often used to do this.
• Detailed process maps can be created to help pin-point where in the process the root causes reside, and what might be contributing to the occurrence.

Improve
The purpose of this step is to identify, test and implement a solution to the problem; in part or in whole. Identify creative solutions to eliminate the key root causes in order to fix and prevent process problems. Use brainstorming or techniques like Six Thinking Hats and Random Word. Some projects can utilize complex analysis tools like DOE (Design of Experiments), but try to focus on obvious solutions if these are apparent.

• Create innovative solutions
• Focus on the simplest and easiest solutions
• Test solutions using Plan-Do-Study-Act (PDSA) cycle
• Based on PDSA results, attempt to anticipate any avoidable risks associated with the "improvement" using FMEA
• Create a detailed implementation plan
• Deploy improvements

Control
The purpose of this step is to sustain the gains. Monitor the improvements to ensure continued and sustainable success. Create a control plan. Update documents, business process and training records as required.

A Control chart can be useful during the control stage to assess the stability of the improvements over time.

OK, thought experiment example. I Googled "control chart" and just picked one based on visual appeal.

So, let's call this Current State Customer Support Email Response Cycle Time and do a quick bit of Photoshopping. The idea here is cycle time from date/time receipt of a customer support email request to the time a response is recorded as "delivered" (not opened and read, just "delivered" -- because that's all we control).

I eyeballed and added the 2 sigma upper and lower "warning limit" lines in yellow.

Let's assume we culled a random sample of n=160 out of our support email server inbox. We find a current state of roughly two days response time, ~58 hours worst case. Sample appears to be roughly normally distributed (though we could test for that), and compliant with Gaussian assumptions for our purposes (though 2 CL "outliers" at n=160 begs a question; it's ~5x what we might expect by The Book. Still...).

• Standard Deviation ("1 sigma") is 3.38 (I had to calculate this from the original data; no biggie).
• C.V. ("Coefficient of Variation," a.k.a "Relative Standard Deviation" or "RSD") is ~7.1%, meaning we can unremarkably expect +/- 7.1% variation around the mean response time, current process (that's what "standard deviation" means -- expected variability).
• The variation spread between the UCL and LCL, then, is about 42.5% relative to the mean.

The RSD is simply a measure of variability relative to the mean. It is useful. High RSD is a red flag, given that a core goal of any QI method is reduction of variation.

OK: Notwithstanding that this appears to be (in our thought experiment) a representative baseline random sample (no evident non-zero trendline, one basic marker of process instability), I'd be wanting to drill down deeper. But, that's another, more subtle issue.

For example, might we isolate all of the encounters which are, say, below -1 sigma (quicker response times), and look for any commonalities (i.e., identifiable "special causes")? As I noted in prior posts discussing HEDIS data examples, I might see a nominally random scatter depicting no apparent relation between cost and quality (below, CAD outcomes by cost proxies), but I'd be on the data-mining lookout for anything unique in that first quadrant. What are the people in the high-quality, low-cost segment doing right?

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OK, so, back to our "control chart," we have some current state data. We then have to decide upon what will constitute a "significant" improvement should we undertake to try a process change. In science, you decide and document this prior to proceeding to your "Do" stage.

The salient (and difficult) question becomes one of declaring something along the lines of "we can reduce response cycle time by 20% with a concomitant reduction in variability" by doing "X".

At this point, "Do X," measure the upshot ("Study"), and "Act" on the basis of your findings.

This stuff is no "thought experiment" abstraction to me. It was my daily life in the 1980's in Oak Ridge (below). I painstakingly wrote the code that rendered this (PDF).

This is admittedly pedestrian"old school" QC stuff, but it's at the heart of being scientific.

ERRATUM

While attending the Lean Healthcare Transformation Summit 2013 "CEO Panel" discussion session last week, I had the irascible thought "my, my, -- what an incredibly diverse group of middle-aged white men." I noted the absence of women CEOs in a tweet.

This just came in my inbox.

THE BLOG COMMENT OF THE DAY, IN A NUTSHELL

Had to Photoshop it.

From a comment on The Health Care Blog today.
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JUNE 11 MEANINGFUL USE STAGE 2 ITEM

...SNOMED CT clinical terminology is not widely adopted among providers and vendors, yet Stage 2 starts in October 2013 for hospitals. In particular, EHRs don’t capture communication codes present in 2014 CQMs, such as a specific code that conveys among physicians the degree of a medical condition, or “exclusion” codes that give a patient’s reason for declining medication or notes a patient doesn’t qualify for the medication, DeLano explains. Nor are most providers yet familiar with using SNOMED for clinical documentation, he adds.

Further, adopting SNOMED codes for clinical documentation is a major task, not so far from the complexity of ICD-10, DeLano contends, but the time needed to focus on SNOMED isn’t available as the industry adopts ICD-10. There are benefits to using SNOMED, but if providers and vendors aren’t ready for it, then they won’t be able to attest for meaningful use, he notes. “Providers think they are good because they are on a certified EHR product, but won’t get the clinical quality measures they want if the codes aren’t properly mapped.”

Asked if the federal government recognizes a gap in SNOMED readiness for Stage 2, Delano says, “I think there is awareness that there will be a shortfall in the reporting of CQMs.”...

Interesting. Concerns have been voiced over the utility of CQMs. e.g.,

Validity of electronic health record-derived quality measurement for performance monitoring

Amanda Parsons, Colleen McCullough, Jason Wang, and Sarah Shih
J Am Med Inform Assoc. 2012 Jul-Aug; 19(4): 604–609.
Published online 2012 January 16.

...We looked across the 11 clinical quality measures to assess where information was documented. The presence of data recognized for automated quality measurement varied widely, ranging from 10.7% to 99.9% (table 2). Measure components relying on vitals, vaccinations, and medications had the highest proportion of information documented in structured fields recognized by the automated quality measures. The majority of diagnoses for chronic conditions such as diabetes (>91.4% across measures), hypertension (89.3%), ischemic cardiovascular disease (>78.8% across measures) and dyslipidemia (75.1%) were documented in the problem list, a structured field used for automated quality measurement. Patient diagnoses not recognized for inclusion in the measure were recorded in the medical history, assessment, chief complaint, or history of present illness, sections that typically allow for free-text entries.

Diagnostic orders or results for mammogram had the lowest proportion (10.7%) of data recorded in structured fields recognized for automated quality measurement. The majority of the information for breast cancer screening was found as scanned patient documents and diagnostic imaging; both sources of information are not amenable for automated electronic queries.

Nearly half of the information for measures that require a laboratory test result, such as control of hemoglobin A1c and cholesterol, was documented in structured fields recognized for automated quality measurement (range 53.4–63.0%). Similarly, only half of the information regarding patient smoking status (53.4%) was recognized for automated quality measurement.

With the exception of medications, vaccinations, and blood pressure readings, practices varied substantially in where they chose to document the data elements required for automated quality measurement.

In estimating the denominator loss due to unrecognizable documentation, the average practice missed half of the eligible patients for three of the 11 quality measures—hemoglobin A1c control, cholesterol control, and smoking cessation intervention (table 3). No statistically significant differences were observed between the e-chart and EHR automated quality measurement scores in the number of patients captured for the denominator for the remaining eight measures. Current EHR reporting would underreport practice numerators for six of the 11 measures—hemoglobin A1c control, hemoglobin A1c screening, breast cancer screening, cholesterol control, cholesterol screening, and smoking status recorded.

...More studies are needed to assess the validity of EHR-derived quality measures and to ascertain which measures are best calculated using claims or administrative data or a combination of data sources. If provider-specific quality measurements are to be reported and made public, as is the plan for the meaningful use quality measures, further analysis is needed to understand the limitations of these data, particularly if they are prone to underestimation of true provider performance.

See also

Inaccurate quality reports could skew EHR incentives: study
By Maureen McKinney
Posted: January 15, 2013 - 1:00 pm ET

Electronically reported clinical quality measures vary widely in accuracy, an obstacle that could hinder the federal government's electronic health-record incentive program, according to a study appearing in the Annals of Internal Medicine.

The problem could lead to the highest quality providers not being given the intended incentives, the study concluded.

Beginning in 2014, participants in the CMS' EHR incentive program will be required to report quality data via EHRs. Currently, most quality-reporting initiatives rely on administrative billing data, which has drawn criticism for a lack of clinical relevance, or manual record review, which is time-consuming. Many experts have pointed to EHR-extracted quality data as the best representation of actual patient care.

But researchers, using 2008 data from more than 1,100 patients treated at a federally qualified health center, found big gaps in sensitivity from one electronic measure to another. For instance, electronic measures significantly underestimated the health center's rates of pneumococcal vaccinations and appropriate use of asthma medication, when compared with manual record review...

“If electronic reports are not proven to be accurate, their ability to change physicians' behavior to achieve higher quality, the underlying goal, will be undermined,” they said in the study...

CQMs sometimes reek of "Quadrant Three."
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More to come...