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Tuesday, October 25, 2011

ACOs? "Another Crock of, uh, Government"?

So, CMS released the CFR "Final Rule" (PDF) governing the incipient Medicare "Accountable Care Organizations" (ACOs) last Thursday (Section 3022 of the PPACA), and I'm busily trying to wrap my head around its 696 pages of regulatory provisions to discern to what extent they might bleed into my REC work. I've already keyword/phrase-searched and indexed everything relating to our space (e.g., "meaningful use," "certified EHR," "HIE," "information exchange," "HIPAA," etc).

ACOs are a pretty politically hypercharged topic, to be sure. In some quarters, outgoing CMS Administrator Dr. Donald Berwick is viewed as a Commie Devil Incarnate.

Pretty nice summation of the ACO intent here:

10 things to know about ACOs

By Michelle McNickle, Web Content Producer
Created 10/25/2011

NEW YORK CITY – A recent report published by the Institute for Health Technology Transformation gave some interesting insight into accountable care organizations (ACOs). Among sections focusing on the origins of the ACO concept and their current state, the report detailed 10 basic things you need to know about ACOs.

1. A physician's role will change dramatically. "The economics of patient-centered care will create significant financial incentives for doctors to do more to coordinate care - most importantly, increase collaboration with other medical professionals," the report read. And in addition, this collaboration, according to the report, will occur within the confines of firm, evidenced-based medicine. "...Physicians will be incented to work in patient-centered, evidence-based practices, interfacing with other physicians and care providers to optimize the patient's health at the lowest possible cost."

2. Patients must be engaged in their care. The report stated ACOs build a competitive edge by engaging patients in the delivery of their healthcare. "ACO models propose patient engagement in decision making that requires consideration not only of the best scientific evidence concerning medical treatment, but also the opportunity for patients and their families to assess prospective treatment approaches in light of their own values and convictions." ACOs promote this type of patient engagement as well as possession of basic knowledge for the patients. This enables them to maintain good health, all while avoiding preventable medical conditions and knowing how to manage existing conditions. And, eventually, this will cause accountability to extend beyond the ACO and into the general public.

3. ACOs will create winners and losers among providers. The report cited Harvard business professor Clayton Christensen and said ACO models can be thought of as disruptive business models. "These disruptive models will need to create alignment of interests of the individual doctor and the team, and all will share accountability when patient care goals are not met." Therefore, for ACOs to be successful and sustainable, they must compete for consumers. "Successful ACOs must give consumers a value proposition that is competitive locally, nationally and globally," the report stated. "Providers that are not accountable and transparent will 'lose,' and those that meet patient needs and improve care will 'win.'"

4. ACOs are a team sport. According to the report, today’s siloed patient care approach won't function in a world of accountable care. In fact, an effective transition to an environment that’s more patient-centered and information-rich requires leaders to become informed consumers of the products of improvement science. "These new approaches will change the way the physicians interact with patients, payers and other clinicians," the report read. "While there will be examples of ACOs established by physicians in isolation from hospitals and health plans, this may not be the ideal approach. The reality is that physicians, hospitals, health plans, and many other healthcare stakeholders each bring unique skills and experiences to help deliver accountable care."

5. Transparency will empower consumers and motivate providers. The report makes clear it’s not possible to have accountable care without having at least one party that the healthcare system is accountable to. "In the case of ACOs, the assumed beneficiary has traditionally been the federal government," the report stated. "Since accountable care models are supposed to save money by doing a better job of coordinating care and making wise treatment decisions, the government (and thus the taxpayer) is better off as a result." But, this view doesn’t reveal the whole story, said the report. In fact, it's the consumer that stands to benefit the most from regulations that improve transparency. "Since providers differ widely on cost and quality, widespread adoption of quality measures is likely to improve patient access to this information."

6. ACOs will require health system redesign. According to the report, this redesign will be more than simply tinkering with business models. "ACOs have become synonymous with the Medicare Shared Savings/Pioneer Programs," it said. "However, this is a serious misnomer. These programs have served as models for increasing accountability and integration within the health system, but do no represent the end goal of health reform." Instead, ACOs seek to align patient and physician incentives and provide sustainable outcomes-based compensation systems. "To that end, the accountable care program is another step on the road to integrated patient-centered care... ACOs are a catalyst for dramatic transformation in the way patient care is delivered in the United States."

7. ACOs must be dynamic learning organizations. "High performing ACOs tend to be learning organizations, where the workforce excels at creating and sharing knowledge," read the report. "This exists where there is a supportive learning environment, concrete learning processes and practices and leadership behavior that reinforces and supports learning." It's no surprise this type of environment engages the workforce, which then leads to successful accountable care. This includes consistent focus on the customer, process and quality improvement, improved efficiency and, in the end, better health outcomes and experiences for the patients.

8. An ounce of prevention is worth a pound of cure - and costs a lot less. According to the report, health systems delivering accountable care could change the way the U.S. health care system works. For example, focus should shift from episodic, acute care provision to wellness and prevention. "This can be achieved through patient engagement and empowerment, improved chronic disease management processes, effective predictive modeling and population health management," said the report. It also added providers need to "be in the business of health, and not just in the sickness business. Emphasis should be placed on wellness and prevention programs, which have shown to improve health outcomes when properly administered."

9. Expect a significant change in transitions of site care and delivery mechanisms. Remote and virtual care will become the norm, said the report. "The value-based care expected of ACOs is a complete diversion from the fee-for-service system, which encourages higher volume of patient visits." As ACOs seek to keep patients healthier, the report stated we’ll likely see a centrifugal shift from hospitals to ambulatory sites. "Additionally, increased utilization of remote patient technologies is feasible," it said.

10. Primary care should be a major focus in the ACO environment. "Because of the potential for improving health and avoiding costly complications of chronic diseases, many of the ACO performance measures relate to performance in primary care," the report read. Additionally, it's recognized that increased investment in primary care is needed to slow the overall rate of growth in healthcare spending. "Together, this supports that it will be critical for ACOs to have a strong foundation of high-performing primary care and to practice evidence-based medicine."

We shall see. Smells like Teen Spirit HMOs to skeptics.

More cautionary observations, from:

One basic problem remains – a problem that is built into the core of the Shared Savings Model: at best, the model permits an ACO to receive 60 percent of the savings that it created, with CMS taking the other 40 percent. To create a dollar in savings, the hospital or medical group must give up a dollar of Medicare revenue. This dollar of gross revenue would make a contribution to both the fixed costs of keeping the hospital or medical group operating and to the marginal cost of providing the service that, if provided, would gain the dollar of Medicare revenue for the organization. Each organization will have to decide whether the sixty cents in shared savings that it can, at most, receive is worth more than the dollar in gross revenue that it is giving up.

But the calculation cannot end there – the organization must also consider the cost of creating and operating an ACO. CMS estimates that the average ACO will need $580,000 in start-up costs and $1,270,000 in annual operating expenses. Even after spending this money, there is the possibility that the organization will incur the costs of creating and operating the ACO but will not receive any shared savings bonus from CMS, because it fails to generate savings and/or fails to score highly enough on quality metrics.

Additionally, an ACO that chooses the second track (the track that permits it to receive 60 percent, rather than 50 percent, of savings generated), risks having to pay CMS a share of any costs that exceed the predicted costs for the ACO’s population of patients.

In other words, the shared savings “bonus” is not really a bonus. Under the program as designed even an efficient, high quality ACO will gain less money from sharing in savings than it would have earned if it had simply continued with business as usual. And there is no real bonus for quality – at best, an ACO can receive the maximum amount of shared savings possible – i.e., at most 60 percent of the savings it created for CMS – but no additional funds for quality. This is a fundamental flaw in the design of the program – a flaw created by Congress, and which only Congress, not CMS, could remedy.

Hmmm... Click the Health Affair Blog graphic above for the link to the full article.

Apropos of the broad topic...

Company Tries Common Sense Approach To Improving Health Care

A California-based health care company has found some common sense approaches to improving care while cutting costs for its Medicare customers.

For example, CareMore offers free rides to the doctor’s office to avoid missed visits; they clip toenails to make sure patients don’t trip on rugs; they’ve set up a wound center to ensure a small cut doesn’t lead to an amputated foot in diabetic patients. These sound like little things, but the company says they’ve had a major impact.

In fact, CareMore reports overall costs are 18 percent lower than the industry average and hospitalization rates are 24 percent below average. The company also points to hospital stays that are 38 percent below normal and amputation among diabetics are an astounding 60 percent lower than average.

CareMore operates 26 centers across the Southwest, with more than 50,000 Medicare Advantage patients. But its philosophy could be spreading now that the massive health care company, Wellpoint, Inc., bought CareMore for $800-million, with 34-million patients nationwide.


Tech note: if you don't see a horizontal embedded mp3 player above, get the plugin.

BTW: Interesting that I had cited in my prior post the Atlantic article "The Quiet Health-Care Revolution" they discussed.

"Here and Now"
is a great NPR radio show, btw.

Below, this is pretty interesting (click the graphic):

Brochure here (PDF).


First, from Mede Analytics:

This paper is excellent. Thorough, a quick read, and non-partisan. You have to register to get the full free PDF copy. Well worth it. to wit:
The “accountable care organization” (ACO) is a major topic of discussion in American health policy. While many definitions of an ACO have been proposed, a general consensus has emerged, defining an ACO in simple terms as a voluntary group of physicians, hospitals and other healthcare providers that is willing to assume responsibility for the quality and cost of healthcare for a clearly defined population attributed to them on the basis of patients’ use of primary care services. If the ACO meets quality benchmarks and reduces per-beneficiary spending below what would otherwise have been expected, it will receive a share of the savings.

Though the ACO label has been around since 2006, it was mentioned in numerous healthcare reform bills proposed in 2009 and was ultimately included in section 3022, the Medicare Shared Savings Program, of the Patient Protection and Affordable Care Act (ACA), which was signed into law on March 23, 2010. Section 3022 did not address many details of the program, leaving it to the Secretary of Health and Human Services (HHS) to make decisions to expand and refine the program within the context of a notice of proposed rulemaking (NPRM) procedure...

Tone of the Final Rule
In view of the continued rancor surrounding healthcare reform and the 1,320 public comments on the proposed rule—some of which were quite critical—the final rule and public announcements made by government officials about it seem to reflect a tone of accommodation and optimism. The final regulation repeatedly points out how CMS has incorporated suggestions made by the public. In the press release announcing the final rule, HHS Secretary Kathleen Sebelius stated, “We are excited to give doctors, hospitals and other providers the flexibility and support they need to work together and focus on making sure patients get the care they need.”2 Similarly, in his op-ed in The New England Journal of Medicine, Berwick expressed his hope that the changes from the proposed rule “create a more feasible and attractive on-ramp for a diverse set of providers and organizations to participate as ACOs.”...

Organization of the Final Rule
At a high level, the final rule’s 696 pages are organized primarily into four sections. It starts with a background section (pages 7-17) that includes an introduction to and overview of value-based purchasing, which provides the philosophical underpinnings of ACOs. The background section also covers the statutory basis for and overview and intent of the Shared Savings Program, as well as a recapitulation of high-level public comments received on the proposed rule.

The second section (pages 17-589), covering the provisions of the proposed rule, summary of and responses to public comments, and provisions of the final rule, accounts for over 80 percent of the document. As with the same section of the proposed rule, it has a “discussion” feel to it, generally presenting for each issue three items: 1) selected public comments or summaries of public comments; 2) HHS’s response to the comments; and 3) the final decision on the issue...

The third section (pages 589-621) is a regulatory impact analysis, which provides an assessment of the impact of the final rule on affected entities and beneficiaries.

The fourth and final section is the text of the final regulation (pages 623-694)...

The long-awaited final rule—lengthy, highly detailed and mind-numbingly complex—constitutes the end of the road for the Medicare Shared Savings Program’s rulemaking process. While the draft regulation was collaborative in tone, it faced numerous critical reviews and a large volume of recommended changes during an extremely active and engaging public comment period. While the Medicare ACO debate has seemed to go on interminably, from the passage of the ACA until the release of the final ACO rule, commercial ACOs—led largely by innovative health plans—have continued to develop and flourish.

True to CMS’s promise to give serious consideration to each and every suggestion for improvement, the final rule strikes the dual tones of accommodation and optimism. In almost every aspect of the regulation—notably with respect to quality measures and the financial models—the final rule is more generous, flexible and supportive to providers. Time will tell whether this voluntary program will regain the momentum and sense of optimism about Medicare ACOs that preceded the proposed rule...

Again, a fine piece of work. It really helps me with my own vetting (which continues). Below, Ken Perez, Mede Analytics SVP of Marketing and Director of Mede's Healthcare Policy Team, addresses the ACO Final Rule topic.


Below, another fine, timely paper, which focuses in particular on a couple stakeholder perspectives:

Executive Summary

...what appears to be growing interest and willingness among both providers and commercial health plans nationwide to collaborate in implementing value- based payment models such as accountable care organizations (ACOs). Providers and health plans are being motivated by a growing sense that costs and budgetary constraints will inevitably require significant movement away from the fee-for-service model. In addition, new payment rules and initiatives within the Medicare and Medicaid programs, such as the value-based purchasing program, hospital readmission penalties, bundled payment demonstrations, and the Medicare Shared savings program are motivating providers to develop the kinds of care platforms and information technology capabilities believed necessary to succeed in a value-based payment environment. Likewise, new provisions in the Affordable Care Act are having a significant motivating impact on health plans, such as the new medical loss ratio standards, new rules tying payment to performance under the Medicare Advantage Star Rating System, the federal authority and enhanced state resources to review “unreasonable” premium rate increases, and new laws to support establishment of state-level health insurance exchanges...

Factors Driving Provider Interest in ACO Contracting
In light of present day conditions, with health care program reimbursement cuts, apparently unsustainable government budget deficits, federal health care access and payment reform attempts, and consensus within the policy community that the government and private sectors must shift away from fee-for-service medicine, many providers have concluded that adoption of value-based payment models are a necessity and will eventually become the dominant form of payment for health care in the United States...
Again, registration is required for access to the free PDF report.

Update: yet another interesting report:

Click the image above for the PDF report. You don't have to register for this one.
High-Performers and New Models of Care Require Advanced Health IT

Our nation’s highest performing health care organizations and practices exhibit many of the attributes of new models of care to promote higher quality, lower cost and greater access. Understanding the attributes that these high-performers share (listed below) and the critical role that health IT plays in enabling them can help shape decisions about the most effective allocation of health IT resources.

Health IT enables health care organizations to optimize clinical, administrative and operational data, including patient and community information, to set goals, identify opportunities for improvement and monitor progress.

Being truly patient-centered includes giving patients electronic access to information in their health care records; educational resources; and self- monitoring and tracking tools between visits. Patient-centered organizations support shared decision-making and secure electronic communication between patients and their providers, and incorporate patient preferences and, increasingly, functional status in health care records.

Health IT and health information exchange enable all providers who care for the patient, as well as patients and family caregivers (or “care leaders”), to access, from across the range of settings, the right information at the right time while effectively managing privacy and security. Such information is drawn from patient records within hospitals and physician offices, as well as information generated by laboratories, pharmacies, health plans and the patients themselves.

The secure exchange of patient data provides an essential platform for care coordination and helps clinicians, care teams and patients to track and manage the patient’s journey through the health care system. Online access to patient data across settings and over time, as well as feedback on performance and “virtual consultations,” enable effective coordination that increases quality, efficiency and access. Reminders and alerts for patients and health care professionals help to eliminate gaps and duplication in care.

Through electronic educational resources, interactive tools, preventive care reminders and electronic communication with care teams, health IT can help patients more effectively understand and manage their health and wellness.

Health IT and health information exchange enable organizations to collect and analyze clinical, administrative and patient-generated data to set goals, identify areas for improvement, assess effectiveness of interventions, and monitor performance related to cost, quality and patient experience – all of which support accountability, transparency and payment reforms.

Online and electronic patient tools, including portals, facilitate timely communication among care teams and patients between visits. Online scheduling and reminders help patients arrange timely access to care when they need to be seen, and “e-care” is more accessible and convenient when face-to-face visits are not required...

Call it P4P, call it ACO, call it Lean Patient-Centered Care, call it Mayo Model, call it whatever. We know what needs to be done. Whether we can muster the constructive, adult, big-picture political will to do it all is entirely another matter. Recall my June 18th, 2011 post "Use Case," wherein I cited medical economist J.D. Kleinke:

As I remarked at the time, "This article was published in the fall of 2005. Change a few NHE numbers and then- leading wonk names, it could have been written yesterday. Read it closely, all of it. It is excellent."

The words of health care futurist Joe Flower continue to ring resonant.
Health care is more unstable than it has been at any time in living memory. That’s pretty scary, but that instability may turn out to be its most important asset in this moment, as the whole industry becomes open to profound change.

As long as I can remember, thoughtful analysts have been saying, “We need to do this differently. This is not working.” In this century, the voices became louder and more insistent, and they spread. But health care has been very slow to evolve in any fundamental way. Even health care reform, when it came through extraordinary political pain and maneuver, was more a way to bolster business as usual, a way to shore up revenue streams and patch holes in the fee-for-service business model, than it was any fundamental restructuring.

Now the ground under our feet is liquefying.

Indeed. I'm just an ordinary citizen, and my REC work is "technical assistance," not "policy" (as my bi-state REC Executive Director curtly reminded me upon learning that I'd launched this personal blog -- for "exceeding your scope"). But, I've been mulling over and writing about all this stuff for quite some time now on my personal "policy blog," predating my current tenure with HealthInsight, and I will keep pushing on.

Not that I claim to have many answers, but I do know what questions need be posed, questions too often lost in the din of our clownish bumper sticker infotainment political culture

More to come. Including, do EHRs actually raise malpractice liability rates? (PDF) And, (still, again) what precisely do we mean by "obtain consent" with respect to HIT/HIE? Relatedly, who "owns" your PHI/ePHI? (And, is that really a Red Herring question?)

Stay tuned...


Wow. I wish I could just take a couple of days off and study this. A great read thus far. What a life.


...As more providers adopt new EHR technology, software design flaws will be identified as the systems are tested. Data coding errors, implementation challenges, and operational failures will occur as the systems are utilized. These errors should decrease over the long term as vendors, providers, and medical liability carriers monitor the new systems and develop process improvements, but there will be early challenges that will also serve to develop case law through legal action. Medical liability claims may also increase as patients gain easier access to their electronic data and discover that their provider may not have followed one or more treatment protocols that are embedded therein. The authors expect that the cost of defending against these claims will increase as more attorneys use electronic legal discovery for both the data and the metadata. These factors are likely to drive up the cost of medical liability insurance until:

  1. the software vendors effectively resolve numerous medico-legal flaws and limitations in their EHR technology and
  2. best practices in selection, implementation and operation become wide spread.
Until these challenges are addressed, medical liability insurance costs are likely to increase even faster than their historical controls in order to compensate the liability carriers for their increased professional liability payouts...

Interesting. Full paper here (PDF). Recall my post last year "First, do no 'Hold Harmless'." I follow these developments intently. I champion what I see to be the major net upside of HIT/HIE, but I am acutely aware of the trust that must be earned -- trust that can easily be destroyed if patients' data are misused (intentionally or otherwise) beyond a miniscule, random degree.

As we push forward with now accelerated widespread HIT/HIE deployment, I have to admit to concerns that critical issues may get glossed over amid the hubbub.

As we move toward the operational launch of our HealthInsight Nevada HIE, for example, we continue to chew over the nuances and implications of patient "consent" under both the baseline provisions of HIPAA regulations and
Nevada Senate Bill 43 (PDF), which authorizes the state to initiate and administer a Health Information Exchange and regulate any other HIEs (such as ours) that come online here.

Our HIE Privacy and Security Task Force (within which I nominally serve as a "staff resource") curiously concluded early on that "Nevada is an opt-in state," notwithstanding that the statute does not say that. The word "opt" appears only twice [15(2)(b) and (c)], each time followed by the word "out." **

Apropos of that:
I belong to a school, a small but hardy school, called “textualists” or “originalists.” That used to be “constitutional orthodoxy” in the United States. The theory of originalism treats a constitution like a statute, and gives it the meaning that its words were understood to bear at the time they were promulgated. You will sometimes hear it described as the theory of original intent. You will never hear me refer to original intent, because as I say I am first of all a textualist, and secondly an originalist. If you are a textualist, you don’t care about the intent, and I don’t care if the framers of the Constitution had some secret meaning in mind when they adopted its words. I take the words as they were promulgated to the people of the United States, and what is the fairly understood meaning of those words.

I do the same with statutes, by the way, which is why I don’t use legislative history. The words are the law. I think that’s what is meant by a government of laws, not of men. We are bound not by the intent of our legislators, but by the laws which they enacted, which are set forth in words, of course. As I say, until recently this was constitutional orthodoxy.

- Justice Antonin Scalia

SB 43 is internally inconsistent on the topic of consent, and looks in places to be a marginally coordinated multi-contributor cut & paste pastiche. But, when you gripe about things like that, the attorneys (we have two on the task force) tend to blow you off with a polite "well, you just don't understand Statutory Construction" reply.

Ahhh... (apologies to Justice Scalia), we must look to "legislative intent" to divine how the lawmakers "construed" their effort. Such was also the conclusion of the Outside Counsel we hired to review our lawyers' "SB 43 Memo."

OK. I read every on-the-record word (click the graphic above for the legislative progress record). Pretty interesting stuff. e.g.,
Subcommittee of the Senate Committee on Health and Human Services March 31, 2011 Page 2 (PDF)

SENATOR KIECKHEFER: Is the intent of section 5, subsection 1, paragraph (e) of the proposed amendment, Exhibit C, to allow the director of the Department of Health and Human Services (DHHS) to determine ownership by regulation?

MARSHEILAH LYONS (Policy Analyst): The intent is to have the director create regulations that address ownership and stewardship of information and data.

LYNN O’MARA (Project Manager, Office of Health Information Technology, Department of Health and Human Services):

The health information exchange (HIE) cooperative agreement needs some requirements to ensure the privacy and security of data, including stewardship and ownership, are addressed. It is an issue on which we are to be receiving additional guidance.

SENATOR KIECKHEFER: I understand the concept of rules governing stewardship of information and data, but ownership is an issue I do not feel comfortable allowing to be decided by regulation.

MS. O’MARA: The Health Insurance Portability and Accountability Act (HIPAA) is clear. The individual decides who can see personal information, so it is like a de facto ownership to the individual. [emphasis mine].

Really? HIPAA says no such thing. Anywhere. PHI "ownership" is neither stipulated nor implied by any stretch.
(to be fair, Ms. O'Mara is neither an attorney nor a legislator.)

But, then, Outside Counsel also recommended that reviews of HIPAA/HITECH federal "legislative intent" might also be warranted.

Right. Comp me a Lexis/Nexis and Westlaw account. I'll do it.

For free.

** You have to wonder whether this is where they glommed onto SB 43 "opt-in."
Senate Committee on Health and Human Services February 17, 2011 Page 9

Ms. O’Mara: ... Section 8 contains the requirements for transmission and participation in HIEs.

SENATOR WIENER: I see this as an “opt-in” law. It is not mandatory for providers to participate. If that is the case, what does it mean to providers who would prefer not to opt-in?

MS. O’MARA: Providers are not required to participate.

Providers, not patients.

This privacy issue gets really complex (once the laywers get off and running, at umpty-hundreds of dollars per hour). But, is "own/not own" a false dichotomy? Where does PHI/ePHI fit within the legal confines of "intellectual property"? And, does "privacy" hinge of answering those questions?

No, IMO.

Much more to come...



I've been sitting on this for quite some time. It's official as of today.

They solicited staff input for our new HIE name. And, they chose mine. I was actually surprised. I like the "pulse" tag line they came up with. Mine were OK, but too much. The graphic above, btw, is just another of my 5-minute Photoshops for temporary concept illustration. They just let the RFP for /logo/graphics/web design. Contact Kym if you want to bid (or know of someone):

I gave them four quick Photoshop renderings (all using stock art), each from patient and provider POVs.

You could render the concept a hundred ways. None the foregoing represent our HIE's official logo/artwork, which are TBA. Just my $0.02. Pleased to have contributed.


Docs turn to Google, Yahoo for health info, survey finds
November 01, 2011 | Molly Merrill, Associate Editor, HealthcareIT News

PHILADELPHIA – Google and Yahoo were cited by 46 percent of physicians in a recent survey as a frequent source of information used to diagnose, treat and care for patients.

The Wolters Kluwer Health 2011 Point-of-Care Survey found that another 32 percent of physicians used these general browsers as an occasional resource. Sixty-three percent of physicians also reported they have changed an initial diagnosis based on new information accessed via online resources/support tools...

That's pretty interesting. Be nice to see a breakdown of what resources are being searched. I also have to wonder what SOAP documentation requirements these queries might fall into (e.g., EHR audit logs).

More to come...

Sunday, October 16, 2011

Telemetry (and other stuff)

Corventis – "Can our bodies become wireless transmitters? The people at San Jose-based Corventis think so. Their Nuvant Mobile Cardiac Telemetry System can detect early heart arrhythmias using a small (2x6 inch) device mounted on a patient’s chest. This sensor sends a constant stream of data to a transmitter that then relays it to a monitoring center. It won FDA approval last year. Even more intriguing is work being done at the University of Illinois where ultrathin, electronic medical monitors are being designed that can be attached to a patient’s skin, like a tattoo..."

I'd already heard about the "tattoo" thing, and had meant to post about it. Getting difficult to keep up with everything; to wit,


Or, "Hot Spotters for nicer people." In the November Atlantic
ELLEN, AN 82-YEAR-OLD widow, lives in Anaheim, California. One Wednesday morning last year, she got on her scale, as she does every morning. One hundred and forty-six pounds—wasn’t that a little high? Ellen felt vaguely troubled as she poured herself a bowl of oat bran.

Half an hour later, the phone rang. It was Sandra at the clinic. She too was concerned about Ellen’s weight, which had jumped three pounds since the previous day. Sandra knew this because Ellen’s scale had transmitted its reading to the clinic over a wireless connection.

Given that Ellen had a history of congestive heart failure, a three-pound weight gain in 24 hours was a potentially dangerous development, a sign of possible fluid buildup in the lungs and increasing pressure on an already stressed heart. Sandra wanted her to come in for an immediate visit: the clinic would provide a car to pick her up and bring her back home. Ellen’s treatment began that very morning and continued for two weeks until she was out of danger. Had the warning signs not been noticed and addressed so quickly, she might easily have suffered a long, painful, and expensive hospitalization.

Dan, a retired letter carrier, is a patient at a clinic in the same system. At 87, he is decidedly frail, his once-sturdy legs now weak and unsteady. He is a classic candidate for a fall of the kind that has injured many of his friends, in some cases leading to weeks in the hospital and months of rehab. The elderly are prone to falls for many obvious reasons, including weak limbs, impaired vision, and medication side effects. But Dan’s doctors knew that some less obvious causes included shag carpets and long, untrimmed toenails. Because of this, they’d sent someone from the clinic to visit Dan’s apartment and make sure that his daughter replaced the 1980s-vintage carpets with low-pile rugs. Dan also visits the clinic regularly for light muscle-training sessions and periodic toenail clipping. Due to these preventive measures, Dan and his fellow clinic patients are one-fifth as likely as comparable patients elsewhere to suffer falls.

Joe, a 79-year-old diabetic, cut his foot when he banged it against a door. When it didn’t heal after a couple of days, he limped into the office of his family physician. After glancing at the cut, his doctor immediately sent Joe to a clinic in the same system as those that treated Ellen and Dan. For diabetics, even small cuts can be a serious matter: untended, they can become infected and contribute to an alarmingly high rate of amputation.
At the clinic, a nurse practitioner cleaned and dressed the wound, and told Joe she wanted to see him there in two days so she could inspect and treat it again—and two days after that, and two days after that, until it was fully healed. The clinic would arrange for transportation if needed. Thanks to the steady, regular care, Joe’s foot healed without any infection or threat of amputation.

Ellen, Dan, and Joe are all real people, though their names have been changed...

Interesting. Well, this is a good time to get around to the "tattoo telemetry" stuff as well.

Electronic 'second skin' blurs technology and biology

SALT LAKE CITY -- In the Aug. 12 issue of the journal Science, Ma (Jack) Zhenqian g of the department of electrical and computer engineering at the University of Wisconsin published a new scientific paper detailing a hair-thin electronic patch that adheres to the skin like a temporary tattoo. Actually, patches are a common way to deliver medications now, but the new patch looks more like a circuit board diagram and is loaded with electrical engineering firsts. The patch will soon replace medical monitoring equipment cables and some other devices, making them wireless, self powered and more accurate...

...Incorporating these devices in patches similar to tattoos would enable biological readings to be remote and unobtrusively recorded day and night, so important events such as a heart arrhythmia or a spike in blood sugar levels are sure to be noticed.

In a very real sense, it is like being able to have a tabletop doctor's office —including sensors, circuits and elements for drawing power and transmitting data — are stuck to the surface of a 30-micrometer- thick, breathable plastic sheet...
So, is there a waft of Creepiness Factor in all this (e.g., like GPS surveillance tracking of your cell phone or OnStar)?

Blueprint for Innovation Encouraging computerized medical device invention
Sandy Weinberg, Ph.D., Ronald Fuqua, Ph.D.

A patient swallows a computerized capsule, providing his physician with a series of images of the gastrointestinal tract. Another patient accesses the computer control on her wheelchair, which raises her to a standing position and follows a carefully designed exercise program to keep her legs from atrophying. A computerized “lab on a chip” provides toxicologists with a complete analysis series from a single sample...
Or, how about
ePetri: a Smartphone-Based Petri Dish
by STANLEY DARMA on Oct 6, 2011

...The culture is placed on an image sensor chip and the phone’s LED screen functions as a scanning light source. The ePetri device is then placed in an incubator, with the image sensor chip connected to a laptop outside the incubator through a cable. The image-sensor takes pictures of the culture, the data is sent to the laptop and so cultures can be monitored as they grow. The technique is apparently particularly useful in the imaging of cells that grow very close to one another.

Instead of using a large, heavy instrument, they now have a lightweight microscope providing high-quality images of cells. The ePetri is able to monitor the entire field, but can still zoom in on areas of interest within the culture. The research team sees many possibilities for their technology, such as drug screening and detection of toxic compounds. It could even provide microscopy-imaging capabilities for other portable diagnostic lab-on-a-chip tools. Right now the team is also working on a more comprehensive system that would include a small incubator, transforming the ePetri into a desktop diagnostic tool.

Makes your head spin, all these developments. I guess, beyond the technology issues ("accuracy and reliability," e.g., sensitivity, specificity, durability) is the business case at the provider of record destination. Will I get paid for having to examine and assess this looming on-call-all-the-time tsunami of data 24/7?


BOSTON – Physicians who once only grappled with learning the language of medicine must now also cope with a health care world that has turned hospitals into factories and reduced clinical encounters to economic transactions, two Beth Israel Deaconess Medical Center physicians lament.

“Patients are no longer patients, but rather ‘customers’ or ‘consumers’. Doctors and nurses have transmuted into ‘providers,’ Pamela Hartzband, MD and Jerome Groopman MD, write in the Oct. 13 edition of the New England Journal of Medicine.

“We are in the midst of an economic crisis and efforts to reform the health care system have centered on controlling spiraling costs. To that end, many economists and policy makers have proposed that patient care should be industrialized and standardized. Hospitals and clinics should be run like modern factories and archaic terms like doctor, nurse and patient must therefore be replaced with terminology that fits this new order.”

The problem, Hartzband and Groopman, note, is that the special knowledge that doctors and nurses possess and use to help patients understand the reason for and remedies to their illness get lost in a system that values prepackaged, off-the-shelf solutions that substitute “evidence-based practice” for “clinical judgment.”...

"...Now some prominent health policy planners and even physicians contend that clinical care should essentially be a matter of following operating manuals containing preset guidelines, like factory blueprints, written by experts.”...

Difficult, all of it. Click the title image above for the full BIDMC article. Click here for my prior musings on issues of clinical judgment, cognitive traps, and Dr. Groopman.


Click the graphic. Well worth your time.



(Uh, I think he's my Sup now)

Yeah, I hate those things.


Text Messaging Among Providers Prevalent Despite HIPAA Compliance, Security Concerns
By Kendra Casey Plank

A majority of physicians use the text messaging capabilities on their so-called smart phones to exchange information about patients with other health care providers, but doing so could be a violation of federal privacy and security rules, a health information technology firm executive said Oct. 17...

HIPAA Concerns
Adam Greene, an attorney with Davis Wright Tremaine LLP, explained to the webinar audience that the HIPAA Security Rule applies to all electronic protected health information and that the broad definition of PHI could apply to data contained in text messages.

For example, a text message between two treating physicians could be considered containing PHI if it includes admission or discharge date information that could lead to the identification of an individual patient. Similarly, a message between a doctor and patient could be considered PHI, and thus covered by HIPAA, if it indicated a treatment relationship, Green said...

Uh, OK, see the proposed "HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act." While inter-clinician text messages are surely not explicitly part of a "Designated Record Set," I wouldn't lean too heavily on that going forward.

to wit:
45 CFR 164.501: Designated record set means:

(1) A group of records maintained by or for a covered entity that is:

(i) The medical records and billing records about individuals maintained by or for a covered health care provider;

(ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or

(iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals.

(2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.

Direct treatment relationship means a treatment relationship between an individual and a health care provider that is not an indirect treatment relationship.

You tell me. ePHI is ePHI. Doctors are "covered entities."


696 pages of light bedtime reading (PDF). For starters, I've indexed all pages citing "meaningful use," "certified EHR," "HIPAA," and "covered entit(ies)."

From Bloomberg:
Health Rules Prod U.S. Hospitals to Form Networks for Care
By Carol Eisenberg and Alex Wayne - Oct 20, 2011 1:12 PM PT

...The U.S. Department of Health and Human Services issued final rules today for so-called accountable care organizations for the elderly and disabled, a centerpiece of the health-care law designed to save as much as $940 million in three years. Savings would be shared between providers and the government.

Participants can keep more savings after reaching targets, and will need to meet about half as many quality measures as first outlined in March. The delayed rule marks a victory for hospitals, clinics and large doctors’ practices that have lobbied to alter draft regulations they viewed as too burdensome and financially risky...

Quality Standards
An ACO’s potential reward will depend on its performance on almost three dozen quality standards. Other changes include a flexible start date in 2012, providing a list of likely patients up front and expanding participation to include rural health clinics and organizations where specialists provide primary care. Health-care providers won’t be required to pay back the government if they don’t hit savings targets...

We shall see. Give that this is tied to the PPACA ("ObamaCare"), should SCOTUS strike down the PPACA over the "Individual Mandate" issue, the ACO piece goes down with the ship.

More to come...